NCT00912678

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Luebeck · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	MMF (Cellcept) and Steroids	Prograf was withdrawn completely after randomization, MMF and steroids were given.
DRUG	Tacrolimus (Prograf)	After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.

Timeline

• Start date: 2002-03-01
• Primary completion: 2006-07-01
• Completion: 2008-10-01
• First posted: 2009-06-03
• Last updated: 2009-06-03

Locations

5 sites across 1 country: Germany