Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00507793

Purpose

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

Condition	Intervention	Phase
Kidney Transplantation	Drug: Sirolimus Drug: Cyclosporine	Phase IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporin Cyclosporine Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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 Outcome Measures:

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.

Enrollment:	385
Study Start Date:	April 2000
Study Completion Date:	June 2002

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507793

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0468E1-4351
Study First Received:	July 26, 2007
Last Updated:	July 26, 2007
ClinicalTrials.gov Identifier:	NCT00507793
Health Authority:	Austria: Federal Ministry for Health and Women

Study placed in the following topic categories:

Sirolimus
Cyclosporine
Clotrimazole

Miconazole
Tioconazole
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009