Study Evaluating Sirolimus in Kidney Transplant Recipients.

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00167947
First received: September 9, 2005
Last updated: March 13, 2008
Last verified: March 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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)
Arms Assigned Interventions
Active Comparator: A 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 "
Experimental: B 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00144
Palermo, Sicily, Italy, 90127
Bari, Italy, 70100
Bologna, Italy, 40138
Cagliari, Italy, 09125
Firenze, Italy, 50139
L'Aquila, Italy, 67100
Milano, Italy, 20162
Pisa, Italy, 56100
Sassari, Italy, 07100
Siena, Italy, 53100
Udine, Italy, 37100
Varese, Italy, 21100
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Italy, decresg@wyeth.com
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney
Transplant

Additional relevant MeSH terms:
Graft vs Host Disease
Renal Insufficiency
Immune System Diseases
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 20, 2014