Title

Minimizing Immunosuppression in Old for Old Kidney Transplantation
Prospective Randomized Controlled Trial to Compare a Calcineurin Inhibitor Free Immunosuppression With a Low Dose Tacrolimus Based Immunosuppression in "Old for Old" Kidney Transplantation.
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    90
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.
Study Started
Mar 31
2002
Primary Completion
Jul 31
2006
Study Completion
Oct 31
2008
Last Update
Jun 03
2009
Estimate

Drug MMF (Cellcept) and Steroids

Prograf was withdrawn completely after randomization, MMF and steroids were given.

  • Other names: Prograf, CellCept

Drug Tacrolimus (Prograf)

After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.

  • Other names: Prograf

MMF and Steroid Group Active Comparator

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

Low-Dose Tacrolimus Group Active Comparator

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

Criteria

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
No Results Posted