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OpenTrials
Completed

NCT Number: NCT00038948

Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

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Key information

Conditions

Renal Transplantation

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age greater than or equal to 13 years.
  • Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
  • Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion criteria

  • Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
  • Patients in whom kidney-pancreas or other multiple organ transplants have been performed

Treatment and study plan

sirolimus

Drug

Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled

Tacrolimus

Drug

Cyclosporine A

Drug

Primary outcomes

  1. Nankivell Glomerular Filtration Rate (GFR)

    Time frame: 52 weeks

    Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.

Secondary outcomes

  1. First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.

    Time frame: 52 and 104 weeks

    Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Jun 7, 2002
Registry last updated
May 14, 2010

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.

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