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

NCT ID: NCT02284464

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Steroids, tacrolimus and mycophenolate

Normal treatment arm

Group Type: ACTIVE_COMPARATOR

Prednisone continuation

Intervention Type: DRUG

Continuation of steroids

Tacrolimus and mycophenolate

Normal treatment for first 90 days, then steroid withdrawal carrying on with the other drugs

Group Type: EXPERIMENTAL

Prednisone withdrawal

Intervention Type: DRUG

Withdrawal of steroids

Interventions

Prednisone withdrawal

Withdrawal of steroids

Intervention Type: DRUG

Prednisone continuation

Continuation of steroids

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sociedad Andaluza de Trasplantes de Organos y Tejidos

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Domingo Hernandez, PhD

Role: PRINCIPAL_INVESTIGATOR

Carlos Haya Hospital

Locations

Vall d Hebron Hospital

Barcelona, , Spain

Bellvitge Hospital

Barcelona, , Spain

Carlos Haya Hospital

Málaga, , Spain

Canarias University Hospital

Santa Cruz de Tenerife, , Spain

Dr. Peset Hospital

Valencia, , Spain

Countries

Spain

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EVITAESTEROIDE-12

Identifier Type: -

Identifier Source: org_study_id