Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00086346

Purpose

The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.

Condition	Intervention	Phase
Liver Transplantation Graft vs Host Disease	Drug: Sirolimus (Rapamune) Drug: Cyclosporine or Tacrolimus	Phase III

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Tacrolimus Cyclosporin Cyclosporine Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy

Further study details as provided by Wyeth:

Primary Outcome Measures:

Change from baseline in calculated glomerular filtration rate at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
First occurence of graft loss or death at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of biopsy confirmed acute rejection at 2, 6, 12, 24, 36, 48, 60 and 72 months. [ Time Frame: 2, 6, 12, 24, 36, 48, 60 and 72 months. ] [ Designated as safety issue: No ]
Subject and graft survival at 12, 24, 36, 48, 60 and 72 months. [ Time Frame: 12, 24, 36, 48, 60 and 72 months. ] [ Designated as safety issue: Yes ]
Change from baseline in creatinine at 6, 12, 24, 36, 48, 60 and 72 months [ Time Frame: 6, 12, 24, 36, 48, 60 and 72 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	December 2002
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: Cyclosporine or Tacrolimus Group A: tablet, dosage is based on trough levels
B: Experimental	Drug: Sirolimus (Rapamune) Group B: tablet or oral solution, dosage is based on trough levels

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than 13 years (age greater than 18 years as required by some local regulations).
Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
6 to 144 months after orthotopic liver transplantation.

Exclusion Criteria:

History of nonhepatic transplantation
Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
Known or suspected malignancy < 5 years before random assignment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086346

Show 42 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor, MD	Wyeth
Principal Investigator:	Trial Manager	For Italy, decresg@wyeth.com
Principal Investigator:	Trial Manager	For Germany, MedInfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For Belgium, trials-BEL@wyeth.com
Principal Investigator:	Trial Manager	For Czech Republic, WPPGCLI@wyeth.com
Principal Investigator:	Trial Manager	For Netherlands, trials-NL@wyeth.com
Principal Investigator:	Trial Manager	For Switzerland, med@wyeth.com
Principal Investigator:	Trial Manager	For UK, ukmedinfo@wyeth.com

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0468H1-313
Study First Received:	June 30, 2004
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00086346
Health Authority:	United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Italy: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Spain: Ministry of Health; Switzerland: Swissmedic; Netherlands: Medicines Evaluation Board (MEB); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Wyeth:

Liver
Transplant

Study placed in the following topic categories:

Sirolimus
Cyclosporine
Clotrimazole
Graft versus host disease
Miconazole

Tioconazole
Graft vs Host Disease
Tacrolimus
Cyclosporins
Homologous wasting disease

Additional relevant MeSH terms:

Anti-Infective Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents

ClinicalTrials.gov processed this record on January 15, 2009