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

NCT00044720

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Kidney Failure, Graft vs Host Disease, Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- Evidence of active infection


- Evidence abnormal chest x-ray


- Patients with HIV.

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Chronic Kidney Failure, Graft vs Host Disease, Kidney TransplantationStudy Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients NCT00044720
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
Official Title  ICMJE An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor
Brief Summary The incidence of efficacy failure at 12 months between two regimens.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Condition  ICMJE
  • Chronic Kidney Failure
  • Graft vs Host Disease
  • Kidney Transplantation
Intervention  ICMJE Drug: Rapamune
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
Actual Enrollment  ICMJE
 (submitted: August 17, 2009)
484
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

  • Evidence of active infection
  • Evidence abnormal chest x-ray
  • Patients with HIV.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00044720
Other Study ID Numbers  ICMJE 0468H1-101164
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP