Study Evaluating Sirolimus in Kidney Transplant Recipients. - Full Text View - ClinicalTrials.gov

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Study Evaluating Sirolimus in Kidney Transplant Recipients.

This study has been completed.

First Received: September 9, 2005 Last Updated: March 13, 2008 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00167947

Purpose

Renal function at 12 months assessed by calculated creatinine clearance.

Condition	Intervention	Phase
Kidney Failure Graft vs Host Disease	Drug: Cyclosporine Drug: Steroids Drug: Rapamune (Sirolimus)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure Kidney Transplantation

Drug Information available for: Sirolimus Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	January 2005
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Assigned Interventions

A: Active Comparator

Drug: Cyclosporine

Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "

Drug: Steroids

Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "

Drug: Rapamune (Sirolimus)

Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "

B: Experimental

Drug: Cyclosporine

Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "

Drug: Steroids

Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "

Drug: Rapamune (Sirolimus)

Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped "

Eligibility

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

Criteria

Inclusion Criteria:

Age is older than 18 years.
End-stage renal disease, with subjects scheduled for kidney transplant.
Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.

Other inclusion applies.

Exclusion Criteria:

Evidence of active systemic or localized major infection.
Use of any investigational drug or treatment up to 4 weeks prior to study entry.
Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab.
Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).
Immunosuppression therapies other than those allowed in the protocol.
Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with SRL) that is not discontinued prior to study entry.

Other exclusion applies.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167947

Locations

Italy

BARI, Italy, 70100

Bologna, Italy, 40138

Cagliari, Italy, 09125

Pisa, Italy, 56100

L'Aquila, Italy, 67100

Milano, Italy, 20162

FIRENZE, Italy, 50139

SIENA, Italy, 53100

Udine, Italy, 37100

Varese, Italy, 21100

Sassari, Italy, 07100
Italy, Lazio

Roma, Lazio, Italy, 00168

Roma, Lazio, Italy, 00144
Italy, Sicily

Palermo, Sicily, Italy, 90127

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Italy, decresg@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0468E-101629
Study First Received:	September 9, 2005
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00167947 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Wyeth:

Kidney
Transplant

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Renal Insufficiency
Cyclosporine
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Cyclosporins

Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Urologic Diseases
Therapeutic Uses
Antifungal Agents
Graft vs Host Disease
Kidney Diseases
Antirheumatic Agents
Dermatologic Agents
Kidney Failure

ClinicalTrials.gov processed this record on November 27, 2009

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