A Study Of CP-690,550 In Stable Kidney Transplant Patients

NCT01710033

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35249-6860, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Medically stable kidney transplant patients 6 or more months after transplantation.

- Subjects must be on mycophenolate mofetil 1-2 gm daily

- In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

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


- Any rejection episodes in the preceding 3 months.


- Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of CP-690,550 In Stable Kidney Transplant Patients
Official Title  ICMJE Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients
Brief Summary This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Kidney Transplant
Intervention  ICMJE
  • Drug: Placebo
    Placebo tables twice daily (BID) for 28 days
  • Drug: CP-690,550 5 mg BID
    CP-690,550 5 mg BID for 28 days
  • Drug: CP-690,550 15 mg BID
    CP-690,550 15 mg BID for 28 days
  • Drug: CP-690,550 30 mg BID
    CP-690,550 30 mg BID for 28 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: CP-690,550 5 mg BID
    Intervention: Drug: CP-690,550 5 mg BID
  • Experimental: CP-690,550 15 mg BID
    Intervention: Drug: CP-690,550 15 mg BID
  • Experimental: CP-690,550 30 mg BID
    Intervention: Drug: CP-690,550 30 mg BID
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: October 16, 2012)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Medically stable kidney transplant patients 6 or more months after transplantation.
  • Subjects must be on mycophenolate mofetil 1-2 gm daily
  • In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

Exclusion Criteria:

  • Any rejection episodes in the preceding 3 months.
  • Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01710033
Other Study ID Numbers  ICMJE A3921007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2012

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