NCT02284464

Steroid Withdrawal and Donor-specific Anti-HLA Antibodies in Renal Transplant Patients

Steroid Withdrawal and Novo Donor-specific Anti-HLA Antibodies in Renal Transplant Patients: a Prospective, Randomized and Controlled Study in Parallel Groups

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Steroids are one of the pillars of immunosuppression for kidney transplant patients but their use is associated with a high rate of complications. Withdrawal of steroids reduces some metabolic and cardiovascular complications, but it may increase the risk of acute rejection. However, little is known about whether steroid withdrawal is associated with the generation of anti-HLA donor-specific antibodies (DSA) and the relation between DSA and clinical and histological data. The aim of this study is to compare the incidence of de novo anti-HLA DSA in stable kidney transplant patients after withdrawing the steroids 3 months after the transplantation as compared with patients who continue with steroids. The hypothesis is that steroid withdrawal will increase the presence of de novo anti-HLA DSA in stable kidney transplant patients

Conditions

• Other Complication of Kidney Transplant
• Renal Transplant Rejection

Interventions

Type	Name	Description
DRUG	Prednisone withdrawal	Withdrawal of steroids
DRUG	Prednisone continuation	Continuation of steroids

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2014-11-06
• Last updated: 2020-04-14
• Results posted: 2020-04-14

Locations

5 sites across 1 country: Spain