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Minimizing Immunosuppression in Old for Old Kidney Transplantation

NCT00912678 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2009-06-03

No results posted yet for this study

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

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Prograf was withdrawn completely after randomization, MMF and steroids were given.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After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.

Sponsors & Collaborators

  • Astellas Pharma GmbH

    collaborator INDUSTRY

  • University of Luebeck

    lead OTHER

Principal Investigators

  • Lutz Fricke, MD, PhD · University of Luebeck

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-03-31
Primary Completion
2006-07-31
Completion
2008-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00912678 on ClinicalTrials.gov