Steroid Withdrawal and Donor-specific Anti-HLA Antibodies in Renal Transplant Patients
Condition: Other Complication of Kidney Transplant; Renal Transplant Rejection
Intervention: Prednisone withdrawal; Prednisone continuation
Intervention description: Withdrawal of steroids; Continuation of steroids
Intervention MeSH terms: Prednisone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney transplant; Immunosuppression; Steroid withdrawal; Donor specific antibodies

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
    

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.