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Completed

NCT Number: NCT00507793

Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

To evaluate the safety and efficacy of different doses of cyclosporine given concomitantly with a fixed dose of sirolimus in kidney transplant recipients. Cyclosporine blood levels, graft rejection rates and renal function will be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 18 years of age
  • End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated, or living-related mismatched donor
  • Patients with secondary kidney transplant must have maintained primary graft for at least 6 months

Exclusion criteria

  • Antibody induction within one week of current transplantation
  • Multiorgan transplants
  • Patients at high-risk of rejection

Treatment and study plan

sirolimus

Drug

cyclosporine

Drug

Primary outcomes

  1. A dose response model using the average cyclosporine blood levels correlated to graft rejection rates and renal function will be used to compare efficacy and safety of different doses of cyclosporine.

Secondary outcomes

  1. Safety evaluations will include physical exams, vital signs, CBC with differential, platelet count, blood chemistries, fasting lipid profiles, BUN or urea, serum creatinine, adverse event monitoring and calculated creatinine clearance.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open-Label Study to Evaluate the Efficacy and Safety of Cyclosporine Reduction in de Novo Renal Allograft Recipients Receiving Sirolimus: a Dose Comparative Study

Important dates

Study start
2000
Study completion
2002
First posted
Jul 27, 2007
Registry last updated
Jul 27, 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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