Phase 4
N=105
Steroid Withdrawal and Donor-specific Anti-HLA Antibodies in Renal Transplant Patients
Other Complication of Kidney Transplant · Renal Transplant Rejection
Bottom Line
View on ClinicalTrials.gov: NCT02284464 ↗Enrolled (actual)
105
Serious AEs
23.8%
Results posted
Apr 2020
Primary outcome: Primary: Cases of Kidney Transplant Patients With DSA — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prednisone withdrawal (Drug); Prednisone continuation (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cases of Kidney Transplant Patients With DSA |
0; 0 | — |
| SECONDARY Mean Score on the Protocol Biopsies in the Two Treatment Groups |
1.18; 1.83; 1.96; 2.6; 0.17; 0.08 | — |
| SECONDARY Number of Participants With Acute Rejection Lesions |
2; 3 | — |
| SECONDARY Incidence of Diabetes Mellitus |
10; 6 | — |
| SECONDARY Lipid Profile |
164; 161; 51; 44.7; 86; 92 | — |
| SECONDARY Blood Pressure |
133; 125; 74.9; 76 | — |
| SECONDARY Renal Function |
209; 148 | — |
| SECONDARY Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups |
0; 1; 3; 11 | — |
| SECONDARY Patient Survival |
39; 36 | — |
| SECONDARY Graft Survival |
39; 36 | — |
| SECONDARY Renal Function |
209; 148 | — |
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
- Male and female patients aged over 18 years with no immunological risk (PRA 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.
Data sourced from ClinicalTrials.gov (NCT02284464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.