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

April 2, 2020 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08907
        • Bellvitge Hospital
      • Barcelona, Spain, 08035
        • Vall d Hebron Hospital
      • Malaga, Spain, 29010
        • Carlos Haya Hospital
      • Tenerife, Spain, 38200
        • Canarias University Hospital
      • Valencia, Spain, 46017
        • Dr. Peset Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female patients aged over 18 years with no immunological risk (PRA <25% and no DSA) who are receiving their first cadaveric or living kidney transplant.
  2. Patients who, three months after the transplantation, are receiving tacrolimus in combination with mycophenolic acid (MPA) or mycophenolate mofetil (MMF) plus steroids, with stable plasma levels of tacrolimus.
  3. No clinical or histological immunological dysfunction before randomization
  4. No de novo anti-HLA DSA at the time of randomization.
  5. Patients who wish to and are able to give written informed consent to participate in the study.
  6. For women, agreeing to use efficient contraception during the study.

Exclusion Criteria:

  1. Patients who receive a multiorgan transplant.
  2. Retransplants.
  3. Presence of DSA before the transplant or at the time of randomization.
  4. Cold ischemia time >30 hours
  5. Patients with serum creatinine >2 mg/dL or proteinuria >1g/day at the time of randomization
  6. Prior episode of severe rejection (II-B-III in the Banff/13 classification) prior to randomization.
  7. Presence of subclinical rejection on the protocol biopsy prior to randomization
  8. Patients with BK-polyomavirus nephropathy at the time of randomization.
  9. Patients with recurrent or de novo glomerulonephritis.
  10. Patients who are being treated with immunosuppressive drugs other than those in the randomized clinical trial in question.
  11. Patients who are positive for the human immunodeficiency virus (HIV) or those who have a severe systemic infection that, in the investigator's judgment, will require continued treatment.
  12. Patients with any present or prior (during the previous 5 years) malignant disease, except basal or squamous cell carcinoma that has been excised.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Steroids, tacrolimus and mycophenolate
Normal treatment arm
Drug: Prednisone continuation
Continuation of steroids
Experimental: Tacrolimus and mycophenolate
Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs
Drug: Prednisone withdrawal
Withdrawal of steroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cases of Kidney Transplant Patients With DSA
Time Frame: 24 months
Measurements of DSA at baseline, and at 3, 6, 12, 18 and 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft Survival
Time Frame: 24 months
Graft survival after kidney transplant in both groups
24 months
Patient Survival
Time Frame: 24 months
Patient survival after kidney transplant in both groups
24 months
Incidence of Diabetes Mellitus
Time Frame: 24 months
Incidence of diabetes mellitus after kidney transplant in both groups at 1, 2, 3, 4, 6, 9, 12, 18 and 24 months
24 months
Blood Pressure
Time Frame: 24 months
Blood pressure after kidney transplant in both groups at 24 months
24 months
Number of Participants With Acute Rejection Lesions
Time Frame: 24 months
Patients with acute rejection lesions (including subclinical rejection) at 24 months according to Banff classification
24 months
Lipid Profile
Time Frame: 24 months
Lipid profile after kidney transplant in both groups at 24 months
24 months
Mean Score on the Protocol Biopsies in the Two Treatment Groups
Time Frame: 24 months
Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant. The scale ranges from 0 to 3, 3 being the worst.
24 months
Renal Function
Time Frame: 24 months
Renal function after kidney transplant in both groups at 24 months measured according to the creatinine (mg/dL) concentrations
24 months
Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups
Time Frame: At 24 months
The Basle scale was used to assess adherence (BAASIS questionnaire) to immunosuppressive therapy.
At 24 months
Renal Function
Time Frame: 24 months
Renal function after kidney transplant in both groups at 24 months measured according to the proteinuria (mg/24 h) concentrations
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Collaborators

Sociedad Andaluza de Trasplantes de Organos y Tejidos

Investigators

  • Principal Investigator: Domingo Hernandez, PhD, Carlos Haya Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVITAESTEROIDE-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Transplant Rejection

Clinical Trials on Prednisone continuation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe