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OpenTrials
Completed

NCT Number: NCT00282217

Study Evaluating Sirolimus in the Treatment of Kidney Transplant

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Renal transplantation
  • Biopsy-confirmed chronic rejection
  • Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion criteria

  • Transplant of any organ other than the kidney
  • Current important infection
  • Acute rejection within 12 weeks prior to inclusion

Treatment and study plan

sirolimus

Drug

Primary outcomes

  1. Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus

Secondary outcomes

  1. Histological parameters at 12 months

  2. Cumulative incidence of biopsy-confirmed acute rejection at 12 months

  3. Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy

Important dates

Study start
2006
First posted
Jan 25, 2006
Registry last updated
Mar 22, 2007

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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