Dataset Information

Early Corticosteroid Cessation vs Long-term Corticosteroid Therapy in Kidney Transplant Recipients: Long-term Outcomes of a Randomized Clinical Trial.

ABSTRACT:

Importance

The 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of corticosteroids is associated with a higher risk of short-term rejection, and the long-term outcomes of patients withdrawn from corticosteroids remain uncertain.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.

SUBMITTER: Woodle ES

PROVIDER: S-EPMC7859872 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesTo determine the long-term survival rates and prognostic factors in kidney transplant (KT) recipients in Jakarta, Indonesia.DesignRetrospective cohort study.SettingA KT centre in Jakarta.ParticipantsWe enrolled 754 consecutive adult recipients who underwent KT between 2010 and 2020.Main outcome measuresRates of 10-year patient, all-cause and death-censored graft survival and their prognostic factors in KT recipients.ResultsThe 10-year patient survival, all-cause survival and death-censored graft survival rates of KT recipients were 74%, 68% and 81%, respectively. The prognostic factors for poor patient survival were a pretransplant dialysis duration>24 months (HR 1.64, 95% CI, 1.08 to 2.49; p=0.02), cardiovascular disease (HR 1.59, 95% CI, 1.11 to 2.31; p=0.01), delayed graft function (DGF) (HR 4.94, 95% CI, 2.76 to 8.82; p<0.001), post-transplant infection (HR 2.63, 95% CI, 1.56 to 4.43; p<0.001) and acute rejection (HR 2.49, 95% CI, 1.20 to 5.15; p=0.01). All-cause graft survival was prognosticated by a pretransplant dialysis duration>24 months (HR 1.74, 95% CI, 1.15 to 2.47; p=0.007), cardiovascular disease (HR 1.65, 95% CI, 1.18 to 2.33; p=0.004), DGF (HR 5.39, 95% CI, 3.13 to 9.28; p<0.001), post-transplant infection (HR 2.46, 95% CI, 1.05 to 4.02; p<0.001) and acute rejection (HR 4.18, 95% CI, 2.23 to 7.84; p<0.001). Factors associated with poor death-censored graft survival were a pretransplant dialysis duration >24 months (HR 2.19, 95% CI, 1.32 to 3.63; p=0.002), cardiovascular disease (HR 1.65, 95% CI, 1.02 to 2.68; p=0.04) and acute rejection (HR 5.52, 95% CI, 2.80 to 10.83; p<0.001).ConclusionsThe survival rates of KT recipients are prognosticated by pretransplant dialysis duration, cardiovascular disease, DGF, post-transplant infection and acute rejection. Stricter eligibility criteria for recipients, more sensitive cross-match testing methods and better infection management strategies may be beneficial for improving the survival rates.