Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
NCT01710020
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- Subjects with end-stage renal disease
- Subjects need hemodialysis 3 times weekly
- 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.
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Descriptive Information | ||||
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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 |
| |||
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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 |
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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 |