Status:
COMPLETED
Steroid Withdrawal and Donor-specific Anti-HLA Antibodies in Renal Transplant Patients
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Collaborating Sponsors:
Sociedad Andaluza de Trasplantes de Organos y Tejidos
Conditions:
Other Complication of Kidney Transplant
Renal Transplant Rejection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 car...
Eligibility Criteria
Inclusion
- 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.
- 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.
- No clinical or histological immunological dysfunction before randomization
- No de novo anti-HLA DSA at the time of randomization.
- Patients who wish to and are able to give written informed consent to participate in the study.
- For women, agreeing to use efficient contraception during the study.
Exclusion
- Patients who receive a multiorgan transplant.
- Retransplants.
- Presence of DSA before the transplant or at the time of randomization.
- Cold ischemia time \>30 hours
- Patients with serum creatinine \>2 mg/dL or proteinuria \>1g/day at the time of randomization
- Prior episode of severe rejection (II-B-III in the Banff/13 classification) prior to randomization.
- Presence of subclinical rejection on the protocol biopsy prior to randomization
- Patients with BK-polyomavirus nephropathy at the time of randomization.
- Patients with recurrent or de novo glomerulonephritis.
- Patients who are being treated with immunosuppressive drugs other than those in the randomized clinical trial in question.
- 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.
- Patients with any present or prior (during the previous 5 years) malignant disease, except basal or squamous cell carcinoma that has been excised.
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT02284464
Start Date
February 1 2015
End Date
December 1 2019
Last Update
April 14 2020
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Vall d Hebron Hospital
Barcelona, Spain, 08035
2
Bellvitge Hospital
Barcelona, Spain, 08907
3
Carlos Haya Hospital
Málaga, Spain, 29010
4
Canarias University Hospital
Santa Cruz de Tenerife, Spain, 38200