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Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease

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NCT01710020

Last updated on February 15, 2020
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Study Location
Pfizer Investigational Site
Orlando, Florida, 32806 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
End-Stage Renal Disease, Hemodialysis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with end-stage renal disease

- Subjects need hemodialysis 3 times weekly

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

- Subjects with evidence or history of clinically significant disease, excluding those
common for subjects with End-Stage Renal Disease (ESRD).

- Subjects with any condition possibly affecting drug absorption.

- Subjects with malignancies with the exception of adequately treated basal cell
carcinoma of the skin.

NCT01710020
Pfizer
Completed
Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease

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Descriptive Information
Brief Title  ICMJE Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
Official Title  ICMJE Phase 1, Open-Label Study Of The Pharmacokinetics, Non-Renal Clearance And Dialyzability Of CP-690,550 In Subjects With End-Stage Renal Disease Undergoing Hemodialysis
Brief Summary There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a second period (Period 2) will be conducted. In Period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • End-Stage Renal Disease
  • Hemodialysis
Intervention  ICMJE Drug: CP-690,550
CP-690,550 10 mg oral powder for constitution
Study Arms  ICMJE Experimental: CP-690,550
Intervention: Drug: CP-690,550
Publications * Krishnaswami S, Chow V, Boy M, Wang C, Chan G. Pharmacokinetics of tofacitinib, a janus kinase inhibitor, in patients with impaired renal function and end-stage renal disease. J Clin Pharmacol. 2014 Jan;54(1):46-52. doi: 10.1002/jcph.178. Epub 2013 Sep 30.


*   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) 		12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2003
Actual Primary Completion Date June 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with end-stage renal disease
  • Subjects need hemodialysis 3 times weekly

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant disease, excluding those common for subjects with End-Stage Renal Disease (ESRD).
  • Subjects with any condition possibly affecting drug absorption.
  • Subjects with malignancies with the exception of adequately treated basal cell carcinoma of the skin.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 NCT01710020
Other Study ID Numbers  ICMJE A3921004
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 Center Pfizer
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

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