Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00263328
First received: December 6, 2005
Last updated: May 17, 2013
Last verified: May 2013
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Purpose
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplantation |
Drug: Tacrolimus Drug: CP-690,550 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Multicenter, Phase 2, Open-Label, Controlled, Extension Study For Stage 1 Subjects Of Study A3921009 To Evaluate The Long-Term Safety And Efficacy Of CP-690,550 Versus Tacrolimus, When Co-Administered With Mycophenolate Mofetil In Renal Allograft Recipients |
Resource links provided by NLM:
MedlinePlus related topics:
Kidney Transplantation
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Tacrolimus
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To evaluate the long-term safety of CP-690,550. [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the long-term efficacy of CP-690,550. [ Time Frame: 8 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treatment group 1
Standard of care
|
Drug: Tacrolimus
Standard of care
|
|
Experimental: Treatment group 2
Treatment group 2 also receives mycophenolate mofetil
|
Drug: CP-690,550
CP-690,550 5 mg BID
|
|
Experimental: Treatment group 3
Treatment group 3 does not receive mycophenolate mofetil
|
Drug: CP-690,550
CP-690,550 10 mg BID
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus)
- Recipient of a first-time kidney transplant
Exclusion Criteria:
- Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
- Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263328
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, California | |
| Pfizer Investigational Site | Active, not recruiting |
| Los Angeles, California, United States, 90057 | |
| Pfizer Investigational Site | Active, not recruiting |
| Palo Alto, California, United States, 94304 | |
| Pfizer Investigational Site | Recruiting |
| San Diego, California, United States, 92123 | |
| Pfizer Investigational Site | Completed |
| San Francisco, California, United States, 94143-0780 | |
| Pfizer Investigational Site | Active, not recruiting |
| San Francisco, California, United States, 94115 | |
| Pfizer Investigational Site | Active, not recruiting |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Pfizer Investigational Site | Completed |
| Aurora, Colorado, United States, 80045 | |
| United States, Illinois | |
| Pfizer Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| United States, Missouri | |
| Pfizer Investigational Site | Active, not recruiting |
| St. Louis, Missouri, United States, 63110-1092 | |
| Pfizer Investigational Site | Active, not recruiting |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Pfizer Investigational Site | Recruiting |
| New York, New York, United States, 10029 | |
| Pfizer Investigational Site | Active, not recruiting |
| New York, New York, United States, 10021 | |
| Pfizer Investigational Site | Active, not recruiting |
| New York, New York, United States, 10065 | |
| United States, Oregon | |
| Pfizer Investigational Site | Active, not recruiting |
| Portland, Oregon, United States, 97210 | |
| United States, Texas | |
| Pfizer Investigational Site | Active, not recruiting |
| Dallas, Texas, United States, 75204 | |
| Pfizer Investigational Site | Active, not recruiting |
| Dallas, Texas, United States, 75246 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | Completed |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00263328 History of Changes |
| Other Study ID Numbers: | A3921021 |
| Study First Received: | December 6, 2005 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
immunosuppression JAK3 inhibitor and kidney transplantation |
Additional relevant MeSH terms:
|
Mycophenolate mofetil Tacrolimus Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013