Skip to main content
OpenTrials
Completed

NCT Number: NCT00912678

Minimizing Immunosuppression in Old for Old Kidney Transplantation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Kidney Transplantation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Transplant Center Cologne (Koeln-Mehrheim), Cologne, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMF (Cellcept) and Steroids

Drug

Prograf was withdrawn completely after randomization, MMF and steroids were given.

Other names: Prograf, CellCept

tacrolimus (Prograf)

Drug

After randomization CellCept was withdrawn completely, low-dose tacrolimus was given.

Other names: Prograf

Primary outcomes

  1. Acute rejection rate

    Time frame: One year

Secondary outcomes

  1. Graft function

    Time frame: One year

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • Astellas Pharma GmbH

Registry information

Official study title

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

Acronym: ESP-CNI

Important dates

Study start
2002
Primary completion
2006
Study completion
2008
First posted
Jun 3, 2009
Registry last updated
Jun 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.