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OpenTrials
Completed

NCT Number: NCT00254709

Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • End stage renal disease
  • Kidney transplantation
  • Both donor and recipient older than 60 years

Exclusion criteria

  • Prior or concurrent transplant of any organ other than the kidney
  • Current clinically significant infections

Treatment and study plan

sirolimus

Drug

Primary outcomes

  1. Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine

Secondary outcomes

  1. Incidence of acute rejections at 3 and 12 months

  2. Patient and graft survival at 3 and 12 months

  3. Incidence and duration of episodes of acute tubular necrosis

  4. Time to recover renal function (creatinine< 2 mg/dl)

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population

Important dates

Study start
2002
Study completion
2005
First posted
Nov 16, 2005
Registry last updated
Jan 31, 2012

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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