Pharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
NCT01710020
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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.
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End-Stage Renal Disease, HemodialysisPharmacokinetics And Dialysability Of CP-690,550 In Subjects With End-Stage Renal Disease
NCT01710020
- Orlando, Florida
- Minneapolis, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| 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 |
| |||
| 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:
| |||
| 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 |
| |||
| 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 | ||||