A Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial Comparing Early (7 Day) Corticosteroid Cessation Versus Long-Term, Low-Dose Corticosteroid Therapy

Woodle, E. Steve; First, M. Roy; Pirsch, John D.; Shihab, Fuad S.; Gaber, A. Osama; Veldhuisen, Paul Van

doi:10.1097/sla.0b013e318187d1da

Cited by 435 publications

(370 citation statements)

References 24 publications

Supporting

Mentioning

340

Contrasting

Unclassified

Order By: Relevance

“…Tacrolimus trough levels were within the target trough range and were similar in the two treatment arms at all-time points throughout the 5-year study (13). MMF dosing was significantly lower in the CSWD group between 4 weeks and 3 years, but not thereafter.…”

Section: Resultsmentioning

confidence: 79%

“…Based on the inclusion and exclusion criteria (13), the subjects in this study were relatively low-risk recipients. Overall 5-year patient and graft survival rates were high (graft survival at 5 years $90%); this is the most likely explanation for the fact that the rate of death and graft loss in subjects with NODAT was not different from those without NODAT in both the CCS and the CSWD groups.…”

Section: Discussionmentioning

confidence: 99%

“…The clinical trial is registered at www.clinicaltrials.gov (NCT00650468) and meets all CONSORT criteria for publication of randomized trials as previously published (13). The study protocol was IRB-approved at each study site and conducted according to IRB standards at each institution.…”

Section: Methodsmentioning

confidence: 99%

“…Woodle et al reported the 5-year results of a multicenter randomized trial of early corticosteroid withdrawal (CSWD) versus chronic corticosteroids (CCS), MMF and tacrolimus in kidney transplantation (13). A secondary endpoint of the trial was the frequency, severity and treatment of NODAT in the two cohorts.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

Pirsch

Henning

First

et al. 2015

American Journal of Transplantation

View full text Add to dashboard Cite

New-onset diabetes after transplantation (NODAT) is an important complication following kidney transplantation. Data from the 5-year early steroid withdrawal double-blind randomized trial were analyzed to determine if steroid avoidance reduced the NODAT risk. Incidence, timing and risk factors for NODAT were evaluated using eight definitions. By American Diabetes Association definition, 36.3% of patients on chronic corticosteroids (CCS) and 35.9% on early corticosteroid withdrawal (CSWD) were diagnosed with NODAT by 5 years. The definition combining fasting blood glucose !126 mg/dL on two occasions or treatment identified slightly more cases of NODAT: CCS (39.3%) and CSWD (39.4%). Through 5 years posttransplant, the proportion of NODAT patients requiring treatment were similar (CSWD 22.5% vs. CCS 21.5%); however, insulin therapy was lower with CSWD (3.7% vs. 11.6%; p ¼ 0.049). By multivariate analysis, only age, but not corticosteroid use, was a significant risk factor for NODAT for more than one definition. Numerical, but not statistically significant trends toward lower NO-DAT rates with CSWD were observed through 5 years for insulin use, HbA1c !6.0% and !6.5% on two occasions. This prospective, randomized trial of CSWD indicates that CSWD has a limited impact in reducing NODAT when compared to low-dose prednisone (5 mg/day from month 6 to 5 years).

show abstract

Section: Resultsmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

Pirsch

Henning

First

et al. 2015

American Journal of Transplantation

View full text Add to dashboard Cite

show abstract

“…A perceived advantage to alemtuzumab induction, over other therapies, is the allowance of a steroid-free regimen following transplant. Many studies have highlighted the benefits of early glucocorticoid withdrawal on kidney transplantation outcomes [2][3][4]. In addition, Alemtuzumab has also demonstrated equal effectiveness in preventing renal graft rejection as conventionally used immunosuppressive induction therapies in high risk patients [5,6].…”

Section: Introductionmentioning

confidence: 99%

Alemtuzumab Equalizes Short Term Outcomes in High Risk PRA Patients: Long Term Outcomes Suffer

M¹,

Ad²,

Ekwenna³

et al. 2017

J Clin Exp Transplant

View full text Add to dashboard Cite

Early Corticosteroid Cessation vs Long-term Corticosteroid Therapy in Kidney Transplant Recipients

et al. 2021

View full text Add to dashboard Cite

IMPORTANCEThe complications of corticosteroids make the inclusion of these drugs in immunosuppressive protocols for kidney transplant patients undesirable. However, cessation of corticosteroids is associated with a higher risk of short-term rejection, and the long-term outcomes of patients withdrawn from corticosteroids remain uncertain. OBJECTIVE To compare long-term kidney transplant outcomes of patients randomized to continue or withdraw corticosteroids. DESIGN, SETTING, AND PARTICIPANTS This prospective multicenter randomized double-blind placebo-controlled trial was conducted between November 1999 and December 2002 with linkage to a mandatory national registry with validated outcome ascertainment until June 8, 2018. The study included 28 kidney transplant centers in the United States, including 386 low-to moderate-immune risk adult recipients of a living or deceased donor kidney transplant without delayed graft function or short-term rejection in the first week after transplant. Analyses were intention to treat. Analysis began September 2018 and ended June 2019. INTERVENTIONS Patients were randomized to receive tacrolimus and mycophenolate mofetil with or without corticosteroids 7 days after transplant. MAIN OUTCOMES AND MEASURES Kidney allograft failure from any cause including death and allograft failure censored for patient death defined by the requirement for long-term dialysis or repeat transplant. RESULTS Of 385 patients, 191 were assigned to withdraw from corticosteroids (mean [SD] age, 46.5 [12.1] years), and 194 patients were assigned to continued corticosteroids (mean [SD] age, 46.3 [12.6] years). The median (interquartile range) follow-up time was 15.8 (12.0-16.3) years after transplant. The adjusted hazard ratios of allograft failure from any cause including death was 0.83 (95% CI, 0.62-1.10; P = .19) and for allograft failure censored for patient death was 0.78 (95% CI, 0.52-1.19; P = .25) and did not differ between the patients assigned to withdraw from corticosteroids vs assigned to continued corticosteroids. Results were consistent in a per-protocol analysis among 223 patients who continued the trial-assigned treatment of corticosteroid withdrawal (n = 114) or corticosteroids (n = 109) through at least 5 years after transplant. The outcomes of trial participants in either treatment group did not differ from similarly treated contemporary registry patients who met trial eligibility criteria and were treated with the same immunosuppressive drugs.CONCLUSIONS AND RELEVANCE Long-term corticosteroids may not be necessary as part of a calcineurin-based multiple drug immunosuppressive regimen in low-to moderate-immune risk kidney transplant recipients.

show abstract

A Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Trial Comparing Early (7 Day) Corticosteroid Cessation Versus Long-Term, Low-Dose Corticosteroid Therapy

Cited by 435 publications

References 24 publications

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

New-Onset Diabetes After Transplantation:Results From a Double-Blind Early Corticosteroid Withdrawal Trial

Alemtuzumab Equalizes Short Term Outcomes in High Risk PRA Patients: Long Term Outcomes Suffer

Early Corticosteroid Cessation vs Long-term Corticosteroid Therapy in Kidney Transplant Recipients

Contact Info

Product

Resources

About