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Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Last updated on October 10, 2019

FOR MORE INFORMATION
Study Location
Albacete, , 2006 Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Failure, Kidney Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Renal transplantation

- Biopsy-confirmed chronic rejection

- Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Transplant of any organ other than the kidney

- Current important infection

- Acute rejection within 12 weeks prior to inclusion

NCT00282217
Pfizer
Completed
Study Evaluating Sirolimus in the Treatment of Kidney Transplant

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Descriptive Information
Brief Title  ICMJE Study Evaluating Sirolimus in the Treatment of Kidney Transplant
Official Title  ICMJE Sirolimus in the Treatment of Histological Defined Chronic Allograft Nephropathy
Brief SummaryThe aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Kidney Failure
  • Kidney Diseases
Intervention  ICMJE Drug: Sirolimus
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 24, 2006)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Renal transplantation
  • Biopsy-confirmed chronic rejection
  • Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion Criteria:

  • Transplant of any organ other than the kidney
  • Current important infection
  • Acute rejection within 12 weeks prior to inclusion
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282217
Other Study ID Numbers  ICMJE 101467
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Spain, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMarch 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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