Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00658359
First received: April 9, 2008
Last updated: June 24, 2014
Last verified: June 2014

April 9, 2008
June 24, 2014
August 2008
March 2015   (final data collection date for primary outcome measure)
  • Long-term efficacy of CP-690,550 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Long-term safety and tolerability of CP-690,550 [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Long-term efficacy of CP-690,550 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Long-term safety and tolerability of CP-690,550 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00658359 on ClinicalTrials.gov Archive Site
  • Additional measures of efficacy of CP-690,550 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Effects of CP-690,550 on health outcome assessments [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Relationship of CP-690,550 concentration and safety/efficacy endpoints [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
  • Additional measures of efficacy of CP-690,550 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Effects of CP-690,550 on health outcome assessments [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Relationship of CP-690,550 concentration and safety/efficacy endpoints [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
A Phase 2, Multicenter, Open-Label, Active Comparator-Controlled, Extension Trial To Evaluate The Long-Term Safety And Efficacy Of CP-690,550 In Renal Allograft Recipients

This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
  • Drug: Cyclosporine
    Standard of care
  • Drug: CP-690,550
    CP-690,550 tablets dosed BID Months 12-72
  • Active Comparator: Treatment Arm 1
    Treatment Arm 1 will also receive standard of care medications
    Intervention: Drug: Cyclosporine
  • Experimental: Treatment Arm 2
    Treatment Arm 2 will also receive standard of care medications
    Intervention: Drug: CP-690,550
  • Experimental: Treatment Arm 3
    Treatment Arm 3 will also receive standard of care medications
    Intervention: Drug: CP-690,550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
178
May 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who successfully completed Study A3921030

Exclusion Criteria:

  • Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants
Both
18 Years to 70 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Portugal,   Spain
 
NCT00658359
A3921050
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

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