Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00044720

Purpose

The incidence of efficacy failure at 12 months between two regimens.

Condition	Intervention	Phase
Chronic Kidney Failure Graft Vs Host Disease Kidney Transplantation	Drug: Rapamune	Phase IV

MedlinePlus related topics: Kidney Failure Kidney Transplantation

Drug Information available for: Tacrolimus Sirolimus Tacrolimus anhydrous

Study Type:	Interventional
Study Design:	Randomized, Open Label
Official Title:	An Open-Label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor

Eligibility

Criteria

Inclusion Criteria

Age: 13 years or older, 40 kgs or more
End-stage renal disease
African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft

Exclusion Criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044720

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

Study ID Numbers:	0468H1-101164
Study First Received:	September 4, 2002
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00044720
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Kidney Transplant

Study placed in the following topic categories:

Sirolimus
Renal Insufficiency
Graft versus host disease
Clotrimazole
Miconazole
Tioconazole
Kidney Failure, Chronic

Tacrolimus
Homologous wasting disease
Urologic Diseases
Renal Insufficiency, Chronic
Graft vs Host Disease
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009