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

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NCT01710033

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35249-6860 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT01710033
Pfizer
Completed
A Study Of CP-690,550 In Stable Kidney Transplant Patients

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A Study Of CP-690,550 In Stable Kidney Transplant Patients
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Kidney Transplant
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
April 2005
April 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01710033
A3921007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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