Clinical Trials Logo
  1. Home
  2. Kidney Transplantation
  3. NCT00556257
  4. Details
NCT00556257 Clinical Trial

Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients

Kidney Transplantation Clinical Trial

Official title:
A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00556257
Other study ID # A3921037
Secondary ID
Status Withdrawn
Phase Phase 2
First received November 8, 2007
Last updated May 27, 2008
Start date August 2007

Study information
Verified date May 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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 this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Recipient of first time kidney transplant

- Between the ages of 18 and 70 years, inclusive

Exclusion Criteria:

- Recipient of any non-kidney transplant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclosporine
Standard of care
• CP-690-,550
CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical biopsy proven acute rejection rate at 6 months 6 months No
Secondary Pharmacokinetics of CP-690,550 12 months No
Secondary Lymphocyte subsets 12 months No
Secondary Posttransplant humoral alloreactivity 12 months No
Secondary Safety and tolerability of CP-690,550 12 months Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT02723591 - To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients Phase 4
Completed NCT05945511 - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed NCT02234349 - Bile Acids and Incretins in Pancreas Kidney Transplant Patients N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Not yet recruiting NCT05934383 - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension N/A
Withdrawn NCT04936971 - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response Phase 4
Not yet recruiting NCT04540640 - Oxygenated Machine Preservation in Kidney Transplantation N/A
Not yet recruiting NCT03090828 - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease N/A
Recruiting NCT02908139 - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients N/A
Terminated NCT02417870 - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation Phase 1/Phase 2
Completed NCT02560558 - Bela 8 Week Dosing Phase 4
Recruiting NCT02154815 - Pre-emptive Kidney Transplantation Quality of Life N/A
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Enrolling by invitation NCT01905514 - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients N/A
Completed NCT02147210 - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1 N/A
Recruiting NCT01699360 - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients Phase 4
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2
Completed NCT01655563 - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation Phase 2

External Links