Early (fifth day) vs. late (sixth month) steroid withdrawal in renal transplant recipients treated with Neoral® plus Rapamune®: four‐yr results of a randomized monocenter study

Sandrini S, Setti G, Bossini N, Chiappini R, Valerio F, Mazzola G, Maffeis R, Nodari F, Cancarini G. Early (fifth day) vs. late (sixth month) steroid withdrawal in renal transplant recipients treated with Neoral^® plus Rapamune^®: four‐yr results of a randomized monocenter study.
Clin Transplant 2009 DOI: 10.1111/j.1399‐0012.2009.01171.x.
© 2009 John Wiley & Sons A/S. Abstract: The most advisable timing for steroid withdrawal (CSWD) after renal transplantation (Tx) is still an open issue. This randomized study has compared early CSWD (at day 5) with late (at month 6) in patients under Neoral + Sirolimus. The primary end point was the percentage of success in CSWD at month 48. Ninety‐six transplants from deceased donors were randomized to withdraw steroids either early (n = 49) or late (n = 47). At four yr, the two strategies were comparable for: success in CSWD (65% in both), graft survival (95% and 98%), patient survival (92% and 96%) creatininemia (1.7 ± 0.3 and 1.6 ± 0.4 mg/dL), side effects, being still on Sirolimus + Neoral (69% and 74%), reversibility of rejection (AR) (all cases), severity of AR (grade 1A/1B: 81% and 63%). The major differences were incidence of AR: at month twelve (48% vs. 30%, p < 0.04), at 48 (53% and 33%, p < 0.03); timing of AR (72 ± 86 d vs. 202 ± 119 d, p < 0.0001). The timing of CSWD influences neither the rate of successful CSWD nor the long‐term results. However, early suspension causes a higher AR rate, mostly arising within month one, but always responsive to steroids. Yet, the early appearance of AR can make patient management easier and safer.     

Rapid steroid withdrawal in hepatitis C virus-positive kidney transplant recipients

The effects of rapid steroid withdrawal (SW) on kidney transplantation (KT) outcome were investigated in 12 HCV+ patients in a prospective cohort study. These results were compared with 17 HCV+ patients who received KT in the prior 2 yr and treated with a standard prednisone taper protocol. SW patients received only 6 d of steroid treatment after transplantation. Eleven received Thymoglobulin and one Basiliximab induction treatment along with a calcineurin inhibitor and mycophenolate mofetil. Patient and graft survival was 92% in SW group (median follow-up 12 months, range 6-17), and 92 and 82% in the historic control group respectively (median follow-up 21 months, range 11-27). In the SW and control group, acute rejection rates were 9 and 18%, and mean creatinine levels at last follow-up 1.30 +/- 0.36 and 1.68 +/- 0.58 mg/dL respectively. Only two SW patients had an increase in liver function tests during follow-up (18%), compared with six patients in the control group (43%). This study demonstrates that rapid SW is safe for HCV+ KT recipients, without an increase in acute rejection episodes or liver function abnormalities in the short term.     

Renal transplant recipient attitudes toward steroid use and steroid withdrawal

Although steroid avoidance and withdrawal in renal transplant recipients (RTR) are actively being evaluated by physicians, the attitudes of recipients toward steroid use have not been systematically studied in the modern era. We conducted a confidential written survey of single-organ adult RTR pertaining to prednisone-related side-effects. Recipients were asked which drug they felt maximized graft life, which drug they wished to avoid if graft life was unaffected, and which drug they had most compliant with. They also rated 16 common immunosuppressive-related side-effects on a Likert scale with 1 meaning complete disagreement and 10 complete agreement with their own prednisone-attributed experience. A comparison of responses based on RTR demographic characteristics was made by ANOVA or chi-square analysis with Bonferroni correction. The questionnaire was completed by 223 recipients, of whom 93% were primary recipients, 57% were cadaveric organ recipients, and 69% were white people, 7% black people, and 23% Asian people. Age at transplant, age at survey and time since transplant were 41.5 +/- 11, 47.5 +/- 11 and 6.0 +/- 5 yr, respectively. For the entire group, overall side-effect profile for prednisone was rated as 6.1 +/- 3 on the Likert scale, while efficacy was rated as 7.3 +/- 3. If offered monotherapy, 67% preferred a calcineurin-inhibitor (CI), 23% mycophenolate mofetil (MMF)/azathioprine (AZA), and 10% prednisone. When asked which drug they would like to discontinue, 19% chose CI, 16% MMF/AZA, and 65% prednisone. Most recipients felt that CI was the most efficacious drug (80%), followed by MMF/AZA (12%), and prednisone (8%). The side-effects reported as most common were unacceptable weight gain (5.8 +/- 3) and bone/joint disease (5.3 +/- 3). The least common side-effects were blood disorders (2.2 +/- 2) and cancer (2.3 +/- 2). Black people were more likely than non-black people to report developing diabetes (p = 0.02), blood disorders (p = 0.003) and headaches (p = 0.003) as a result of prednisone use. Males reported more liver damage (p = 0.01) while females reported more body fat (p = 0.01) and fluid retention (p = 0.006). RTR >5 yr post-transplant reported more infections (p = 0.008), skin/hair problems (p = 0.02), gastrointestinal irritation (p = 0.02), and bone disease (p = 0.02) compared with RTR <1 yr. Donor source and recipient age did not determine any responses. If given a 'risk-free' choice, the majority of recipients prefer withdrawal of steroids over other agents. Demographic data may be used to predict prednisone-related side-effects and guide steroid use in this population. Study designs related to steroid withdrawal should account for patient preferences in this context.     

Renal function in renal or liver transplant recipients after conversion from a calcineurin inhibitor to sirolimus

Two Six-month pilot studies were conducted in renal (n = 17) or liver (n = 15) transplant recipients to evaluate renal function after conversion from calcineurin inhibitor (CI)- to sirolimus (SRL)-based immunosuppression. After an SRL loading dose, doses were individualized to achieve whole blood trough levels of 10-22 ng/mL. Overall, serum creatinine did not change from baseline to six months post-conversion but an improvement from 219.9 to 201.4 micromol/L at three months was noted in renal transplant recipients (p < 0.05). Another finding was a numerical increase in the mean glomerular filtration rate (GFR) from 26.8 to 33.2 mL/min/1.73 m(2) at six months among liver transplant recipients (NS). All patients survived and all grafts were functioning at the end of the study. In conclusion, renal function remained stable, with a tendency towards improvement, after abrupt conversion from CI- to SRL-based therapy in renal or liver transplant recipients with moderate renal insufficiency.     

Steroid withdrawal in pediatric and adult renal transplant recipients

Corticosteroids are still a cornerstone in the immunosuppressive regimen in pediatric renal transplant recipients despite their numerous side effects, such as inhibition of longitudinal growth, body disfigurement, arterial hypertension, cardiovascular complications, osteopathy, and others. Previous attempts to spare steroids in cyclosporine (CsA)-based protocols have been associated with an increased risk for acute rejection episodes. The recent introduction of more-potent immunosuppressive medications, such as mycophenolate mofetil (MMF), have, however, renewed interest in steroid-sparing protocols to avoid or ameliorate steroid-associated side effects. Recent studies in Caucasian adult renal transplant recipients receiving CsA and MMF have shown a beneficial effect of late (6 months post transplant) steroid withdrawal on steroid-associated side effects without the burden of an increased rate of acute rejection episodes. These favorable results compared with previous reports in patients on CsA and azathioprine (AZA) can be ascribed to the higher immunosuppressive potency of MMF compared with AZA. We have shown in a retrospective case control study in 40 pediatric renal transplant recipients that late steroid withdrawal is safe and successful in stable patients under an immunosuppressive maintenance therapy with CsA and MMF. The Mid-European Study Group on Pediatric Renal Transplantation and the Arbeitsgemeinschaft für Pädiatrische Nephrologie are currently performing a prospective randomized trial to validate these observations.This work was presented in part at the IPNA Seventh Symposium on Growth and Development in Children with Chronic Kidney Disease: The Molecular Basis of Skeletal Growth, 1–3 April 2004, Heidelberg, Germany     

Steroid withdrawal in living donor renal transplant recipients using tacrolimus and cyclosporine: a randomized prospective study.

Steroids have been a mainstay of immunosuppressive regimens in renal transplantation despite their adverse effects. The introduction of new immunosuppressant has improved the survival rates and prompted trials of steroid withdrawal. We conducted a randomized prospective study to compare steroid withdrawal at 6 months post-transplant between tacrolimus + mycophenolate mofetil (MMF) (FK group) versus cyclosporine A + MMF (CsA group). Steroid was withdrawn at 6 months post-transplant under the condition of no rejection episode proven by biopsy and maintenance of serum creatinine level <2.0 mg/dl. Fourteen recipients were excluded because of acute rejection within 6 months or protocol violation. Steroid could be tapered off in 62 in FK group and 55 in CsA. Three cases in FK group and five in CsA had acute rejection within another 6 months after steroid withdrawal (P > 0.05). At 12 months, the incidence of post-transplant diabetes was 18.6% vs. 8.0% in FK and CsA group. And hypercholesterolemia was presented in 8.5% vs. 2.0%, hypertension in 47.5% vs. 56.0%, and serum creatinine level 1.18 +/- 0.24 mg/dl vs. 1.18 +/- 0.20 mg/dl, respectively (P > 0.05). Steroid withdrawal may be carried out successfully using both FK and CsA with MMF, but long-term follow-up is necessary.     

Early steroid withdrawal in HIV-infected kidney transplant recipients: Utilization and outcomes

Kidney transplant (KT) outcomes for HIV-infected (HIV+) persons are excellent, yet acute rejection (AR) is common and optimal immunosuppressive regimens remain unclear. Early steroid withdrawal (ESW) is associated with AR in other populations, but its utilization and impact are unknown in HIV+ KT. Using SRTR, we identified 1225 HIV+ KT recipients between January 1, 2000, and December 31, 2017, without AR, graft failure, or mortality during KT admission, and compared those with ESW with those with steroid continuation (SC). We quantified associations between ESW and AR using multivariable logistic regression and interval-censored survival analysis, as well as with graft failure and mortality using Cox regression, adjusting for donor, recipient, and immunologic factors. ESW utilization was 20.4%, with more zero HLA mismatch (8% vs 4%), living donors (26% vs 20%), and lymphodepleting induction (64% vs 46%) compared to the SC group. ESW utilization varied widely across 129 centers, with less use at high- versus moderate-volume centers (6% vs 21%, P < .001). AR was more common with ESW by 1 year (18.4% vs 12.3%; aOR: _1.081.61_2.41, P = .04) and over the study period (aHR: _1.021.39_1.90, P = .03), without difference in death-censored graft failure (aHR _0.600.91_1.36, P = .33) or mortality (aHR: _0.751.15_1.77, P = .45). To reduce AR after HIV+ KT, tailoring of ESW utilization is reasonable.     

Early steroid withdrawal in solitary pancreas transplantation results in equivalent graft and patient survival compared with maintenance steroid therapy

Although steroid withdrawal in simultaneous kidney pancreas transplantation has been shown to be feasible, the results of early steroid withdrawal in immunologically solitary pancreas transplantation are not well known. This study evaluated an early steroid withdrawal protocol in this group. The results of steroid withdrawal at 21 d post-transplant in solitary pancreas transplant recipients was compared with a control group consisting of solitary pancreas transplant recipients maintained on steroids (MG). Additional immunosuppression consisted of rabbit anti-thymocyte globulin induction followed by tacrolimus and mycophenolate mofetil in both groups. The withdrawal group (WG, n = 22) consisted of 11 pancreas transplant alone (PTA), six pancreas after kidney (PAK), and five simultaneous cadaveric pancreas living kidney (SPLK) recipients. The steroid maintenance group (MG, n = 32) consisted of 8 PTA, 11 PAK, and 13 SPLK recipients. Recipient and donor demographic characteristics were similar. Seventy eight percent of MG patients had infection-related complications in the first year compared with 50% of the WG patients (p = 0.04). The one-yr rejection, pancreas graft, and patient survival rates were 27.3% 95.5%, and 100% in the WG, and 37.5%, 81.3%, and 93.8% in the MG respectively and not significantly different. We conclude that early corticosteroid withdrawal in isolated pancreas transplantation results in fewer infections and can be achieved without an increased risk of rejection or graft loss over the first year.     

Cyclosporin A withdrawal in live related renal transplantation: long-term results

Cyclosporin A (CsA) withdrawal after 1 yr of stable graft function has been shown to be beneficial in cadaveric renal transplantation. This strategy could be even more suitable for 'immunologically advantaged' grafts as in live related renal transplantation. We report the long-term outcome of patients in a live related transplantation programme undergoing early (between 1989 and 1992) and late (1993 onwards) CsA withdrawal as compared with those on long-term low dose CsA (1993 onwards). Two-hundred and fifty-two patients were divided into three groups based on the following immunosuppressive protocol: group ECyW (n=99), early CsA withdrawal (9 months after transplantation); group LCyW (n=44), late CsA withdrawal (median 16 months, range 13--22 months after transplantation); and group LDCy (n=109), long-term low dose CsA. The median period of follow-up was 66 months after transplantation (range 43--84 months). There was no difference in the actuarial 6-yr patient or graft survival among the three groups. Acute rejection episodes were more frequent in ECyW (54.4%) than in LDCy (31.8%) and LCyW (23.8%) (p=0.001). The risk of developing late (> or =9 months) acute rejection was highest in ECyW 32/99 (32.3%) as compared with LCyW 8/44 (18.4%; p=0.08) and LDCy 8/109 (7.3%; p=0.0001). Of the 32 ECyW patients who developed acute rejection episodes after CsA withdrawal, 13 (40.6%) lost their grafts either due to uncontrolled acute rejection or to chronic rejection. Chronic rejection was higher in ECyW (24%) than in LCyW (11%; p=0.04) and LDCy (17%; p=0.17). Antihypertensive requirement was highest in patients maintained on low dose CsA. Graft function, as measured by serum creatinine levels, was significantly better in LCyW (1.24+/-0.4 mg%) as compared with ECyW (1.49+/-0.5 mg%) and LDCy (1.48+/-0.6 mg%). Early CsA withdrawal after live related renal transplantation is associated with a significant risk of acute rejection and subsequent chronic rejection. Slow withdrawal after 1 yr is safe and more economical than the long-term administration of low dose CsA.     

Early steroid withdrawal results in improved patient and graft survival and lower risk of post‐transplant cardiovascular risk profiles: A single‐center 10‐year experience

Long‐term use of steroids results in predictable secondary effects that can lead to increased morbidity and mortality. In this study, we present 10 years worth of data of early steroid withdrawal (ESW) immunosuppression consisting of mycophenolate, sirolimus, and tacrolimus. From 2003 to 2013, 563 kidney transplant recipients were weaned off steroids prior to discharge. We compared outcomes with that of our 65 historical controls maintained on steroids. We analyzed graft and patient survival and determined the incidence of steroid‐related comorbidities such as hypertension, hypercholesterolemia, diabetes, coronary artery disease, and weight gain. Patients on ESW maintenance immunosuppression had improved patient and graft survival compared to controls. (HR: 0.23; P≤.011, 0.57; P=.026). Rates of biopsy‐proven acute rejection were not different among both groups (HR: 1.24; P=.610). Incidence of post‐transplant diabetes were reduced but not statistically significant (OR: 0.67; P=.138). Additionally, the development of hypertension (OR: 0.86, P≤.01), hypercholesterolemia (RR: 0.82; P=.027), CAD (RR: 0.43; P=.002), and >20 lbs. weight gain (RR: 0.29; P≤.01) was significantly improved over 10 years following initiation of ESW protocols. Early steroid withdrawal in renal transplant recipients results in improved patient and graft survival as well as better rates of post‐transplant comorbid conditions.     

Steroid withdrawal in pancreas transplant recipients

BACKGROUND: Numerous studies of steroid withdrawal have been carried out in kidney and liver transplant recipients, but only a few in pancreas transplant recipients. Yet, pancreas transplant recipients could have significant long-term benefits from steroid withdrawal. METHODS: We performed a retrospective analysis to determine the feasibility of steroid withdrawal in pancreas transplant recipients. RESULTS: Of 360 recipients who underwent a pancreas transplant between January 1, 1994 and June 30, 1998, 14 attempted steroid withdrawal (12 simultaneous pancreas-kidney [SPK]; 2 pancreas transplant alone [PTA]). Reasons for steroid withdrawal were bone fractures (n = 3), psychiatric disorders (n = 2), severe acne (n = 1), recurrent infections (n = 4), and problems with hypercholesterolemia or hypertension (n = 4). All 14 were maintained on tacrolimus and mycophenolate mofetil (MMF) immunosuppression, except for 1 who was on tacrolimus and azathioprine (AZA). Of the 14 recipients, 11 had no episodes of acute rejection before steroid withdrawal. The remaining 3 had one or more acute rejection episodes. Of the 14 recipients, 10 (72%) currently remain off steroids (mean follow-up 18 months, range 5-51 months). However, 4 recipients have resumed steroids: 2 after an acute rejection episode (at 2 and 21 months post-withdrawal) and 2 because of leukopenia (WBC < 3000) and an inability to tolerate full-dose MMF. Steroid withdrawal was unsuccessful in both PTA recipients and in 2 of the 12 SPK recipients. All 14 recipients currently have a functioning pancreas graft. However, 1 of the SPK recipients, in whom steroid withdrawal failed, has developed chronic kidney rejection and is now back on hemodialysis awaiting a retransplant. CONCLUSION: Steroid withdrawal is possible in up to 70% of pancreas transplant recipients. Further studies are necessary to define ideal candidates for steroid withdrawal. Based on the results of this analysis, we have launched a prospective, randomized trial of steroid withdrawal in pancreas transplant recipients.     

Efficiacy of recombinant human growth hormone in pediatric renal transplantation patients after withdrawal of steroid therapy: Report of two cases

The effects of recombinant human growth hormone (rhGH) were examined in 2 girls without any endocrine abnormalities who showed growth retardation after renal transplantation. After transplantation they received methylprednisolone, which was discontinued 5 years before (in one child), and 3 months after (in the other child) the start of rhGH treatment. The patients received cyclosporine, mizoribine, and azathioprine as immunosuppressive therapy before and during rhGH therapy, 1.0 IU/kg per week divided into 6 doses administered subcutaneously. Growth evaluation on the basis of height standard deviation score (SDS) and growth velocity SDS demonstrated catch-up growth in both cases. Skeletal maturation did not proceed, and their pubertal stage remained unchanged during rhGH treatment. In both cases, renal function was stable and no adverse reaction was noted during rhGH treatment.     

Transmission of a pancreatic adenocarcinoma to a renal transplant recipient

Transmission of donor tumours in solid organ transplant recipients is rare, but has been reported with fatal outcome in some cases depending on the original tumour type and location. We report a case of a pancreatic adenocarcinoma of donor origin presented as lymphangitis carcinomatosa of the lung in a renal transplant recipient 9 months after transplantation, which is likely to have contributed to the death of the patient 15 months after transplantation. The donor tumour was originally diagnosed on adrenal tissue removed from the donor kidney during bench preparation. At the time of the diagnosis this kidney and the liver of the multi-organ donor had been transplanted. The liver patient was urgently retransplanted within 24 h. The renal recipient opted not to have a transplant nephrectomy having been made aware of the risk of tumour transmission. The contralateral kidney was discarded. Management of recipients with potential transmission of initially undiagnosed donor malignancy is difficult. Early transplant nephrectomy may be the safest option.     

A randomized exploratory trial of steroid avoidance in renal transplant patients treated with everolimus and low-dose cyclosporine.

BACKGROUND: Everolimus and cyclosporine exhibit synergistic immunosuppressive activity when given in combination. In this randomized trial, we explored whether the use of everolimus associated with low-dose cyclosporine could allow an early avoidance of steroids in de novo renal transplant recipients. METHODS: In this exploratory multicenter trial, 65 out of 133 patients treated with basiliximab (days 0 and 4), everolimus 3 mg/day and cyclosporine were randomized to stop steroids on the seventh post-transplant day (group A), whereas the remaining 68 continued low-dose steroid treatment (group B). RESULTS: During the follow-up, 30 patients of group A (46%) resumed steroids. According to the intention-to-treat analysis, the 3-year graft survival rate was 95% in group A and 87% in group B (P = ns). There were more biopsy-proven rejections in group A, the difference being of borderline significance (32% vs 18%; P = 0.059). After 3 years, mean creatinine clearance was 52.3 +/- 17.1 ml/min in group A and 52.2 +/- 21.5 ml/min in group B. It was similar in the group A patients who experienced rejection (49.8 +/- 14.7 ml/min) and those who did not (53.6 +/- 18.3 ml/min; P = 0.319). Mean serum cholesterol and triglyceride levels were, respectively, less than 250 mg/dl and less than 200 mg/dl in both groups, without any significant difference. Vascular thrombosis (0 vs 11.7%; P = 0.0043) was more frequent in group B. CONCLUSIONS: Treatment based on everolimus and low-dose cyclosporine allowed excellent renal graft survival and stable graft function at 3 years. An early discontinuation of steroids increased the risk of acute rejection, but was associated with a better graft survival in the long-term. However, it was well tolerated only by 54% of patients.     

Bladder carcinoma among live-donor renal transplant recipients: a single-centre experience and a review of the literature

OBJECTIVES

To present our experience with bladder cancer among a renal transplant population and to review critically the relevant literature.

PATIENTS AND METHODS

In all, 1865 renal graft recipients were followed for a mean (sd ) of 6.5 (5) years. Seven recipients (all men) developed a urothelial bladder tumour. The stage and grade of the tumours were determined. The method of the treatment was selected on the basis of the tumour characteristics and graft function. Patients were regularly followed; the endpoints were cancer‐specific survival, recurrence or metastasis.

RESULTS

All patients presented with gross haematuria. There was non‐muscle‐invasive disease in two patients who were treated by transurethral resection and adjuvant intravesical bacille Calmette‐Guérin immunotherapy. One patient died 24 months later due to complications of end‐stage renal disease. To date the second patient is alive and free of the recurrence. Five recipients with muscle‐invasive disease had a radical cystectomy and orthotopic bladder substitution. The mean (sd ) time to the last follow‐up or death was 14.6 (3.1) months. Three patients died with stable graft function; two from distant metastasis and one from a cerebrovascular stroke. The remaining two patients are still alive, free of disease and with good graft function.

CONCLUSIONS

Urothelial bladder tumours are generally uncommon. The presence of haematuria in renal allograft recipients should be thoroughly investigated. Early diagnosis and prompt treatment are required for managing such tumours, because they are aggressive. Orthotopic bladder substitution is feasible with a good functional outcome for patients in whom cystectomy is indicated.     

Steroid minimization for sirolimus‐treated renal transplant recipients

Matas AJ, Granger D, Kaufman DB, Sarwal MM, Ferguson RM, Woodle ES, Gill JS. Steroid minimization for sirolimus‐treated renal transplant recipients.
Clin Transplant 2011: 25: 457–467. © 2010 John Wiley & Sons A/S. Abstract: Steroids are associated with a myriad of post‐transplant side effects. Therefore, as new immunosuppressive drugs have been developed, attempts have been made to minimize steroid exposure. Sirolimus (SRL) has been demonstrated to have efficacy in early and late post‐transplant immunosuppression. Accordingly, numerous trials have studied steroid minimization (early and late post‐transplant) in the context of SRL‐containing protocols (either with or without a calcineurin inhibitor). We herein review these trials and show that recent studies have determined that both late steroid withdrawal and early rapid discontinuation can be successful with SRL immunosuppression.     

Long-term effects of steroid withdrawal in kidney transplantation

The long-term graft function after withdrawal of steroids from maintenance immunosuppression was analyzed in 98 kidney recipients (59 on cyclosporin monotherapy, 39 on cycloporin plus azathioprine) who had not developed an early rejection episode when prednisolone was discontinued. Seven years after steroid withdrawal the probability of an increase in serum creatinine (>20% of baseline levels) was 51%. The increase in creatinine was associated with sclerosing arteriopathy as a marker of chronic rejection in 29 of 43 graft biopsies. The addition of azathioprine had no, effect on the stability of long-term graft function and did not influence the 7-year graft survival rate in this highly selected group of patients.     

Steroid withdrawal five days after renal transplantation allows for the prevention of wound-healing complications associated with sirolimus therapy

Abstract: Background: Sirolimus (SRL) can increase the risk of wound complications. In this study, we investigated the impact of steroids when added to SRL, in this side effect. Methods: One hundred and forty‐eight patients entered prospective studies comparing early (fifth day) with late (sixth month) steroid withdrawal. All patients were on SRL, added either to Tacrolimus (n = 56) or to cyclosporine (n = 97). At 15th day after transplantation, 68 patients were on steroids (On‐St group) and 80 were not (Off‐St group). Wound complications considered were as follows: dehiscence, lymphocele, wound leakage, hematoma and seromas. Risk factors under analysis were as follows: body mass index, diabetes, rejection, creatininemia, length of dialysis before transplantation, recipient age, being on steroids at 15th day, SRL levels. Results: The overall incidence of wound complications was significantly lower in Off‐St group than in On‐St group: 18.8% vs. 45.6%, respectively (p < 0.0004). In detail, lymphocele: 5.0% vs. 32.3% (p < 0.0001); dehiscence 0% vs. 10.3% (p < 0.009), leakage 6.2% vs. 8.8% (p = NS), seromas 1.4% vs. 7.5% (NS). At multivariate analysis, the addition of steroids to SRL increases 4.2‐fold the risk for wound complications. Conclusions: Early steroid withdrawal is effective in preventing both the incidence and the severity of wound‐healing complications because of SRL regime, even when started with a loading dose.