Minimizing Immunosuppression in Old for Old Kidney Transplantation (ESP-CNI)

University of Luebeck

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Tacrolimus (Prograf); Drug: MMF (Cellcept) and Steroids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00912678

ESP-2004-1

Details and patient eligibility

About

Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the decreased injury threshold of older grafts may limit the benefits of transplantation in these patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year prospective multicenter randomized controlled trial. 90 kidney transplant recipients > 65 years with cadaveric grafts (> 65 years) from 5 centers were enrolled and received baseline immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids. Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were performed after one year. The investigators' primary hypothesis is that the biopsy proven rejection rate in the MMF group is not significantly different compared to the LD-Tac group after one year. The investigators' secondary hypothesis is that graft function in the MMF group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to the graft function in the LD-Tac group.

Enrollment: 90 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receiving a cadaveric kidney transplant (first or re-transplant)
• Patients must met the criteria of the EUROTRANSPLANT program
• Organ allocation with the framework of EUROPEAN SENIOR PROGRAM (ESP) by EUROTRANSPLANT
• Written consent

Exclusion criteria

• Not fulfilled inclusion criteria
• Cadaveric kidney from "non heart beating donors"
• One or more than one steroid resistant acute rejections within the first 3 weeks after transplantation
• Two or more than two steroid sensitive rejections (more than 2 administered steroid boli) within the first 3 weeks after transplantation
• Tacrolimus trough level > 10ng/ml in three consecutive measurements
• Allergy against macrolide antibiotics or tacrolimus
• Systemic steroid therapy at study entry not related to transplantation
• History of Malignancy
• Clinical relevant uncontrolled infections, heavy diarrhea, vomiting or active ulcer disease
• Patients who are enrolled in other clinical studies or were enrolled in other clinical studies 28 days before transplantation
• Patients under medication not approved by the German Ministry of Health

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

MMF and Steroid Group

Active Comparator group

Description:

Group of Patients randomized to MMF and Steroid maintenance immunosuppression after 3 months (Tacrolimus withdrawal)

Treatment:

Drug: MMF (Cellcept) and Steroids

Low-Dose Tacrolimus Group

Active Comparator group

Description:

Patients randomized to withdrawal of MMF after 3 months and maintenance immunosuppression with low-dose tacrolimus and Steroids

Treatment:

Drug: Tacrolimus (Prograf)