Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01710033
Other study ID # A3921007
Secondary ID
Status Completed
Phase Phase 1
First received October 16, 2012
Last updated November 26, 2012
Start date September 2003
Est. completion date April 2005

Study information

Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date April 2005
Est. primary completion date April 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Medically stable kidney transplant patients 6 or more months after transplantation.

- Subjects must be on mycophenolate mofetil 1-2 gm daily

- In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

Exclusion Criteria:

- Any rejection episodes in the preceding 3 months.

- Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Placebo tables twice daily (BID) for 28 days
CP-690,550 5 mg BID
CP-690,550 5 mg BID for 28 days
CP-690,550 15 mg BID
CP-690,550 15 mg BID for 28 days
CP-690,550 30 mg BID
CP-690,550 30 mg BID for 28 days

Locations

Country Name City State
Netherlands Pfizer Investigational Site Unknown Rotterdam
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Livingston New Jersey
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site St Louis Missouri
United States Pfizer Investigational Site St. Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550 Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 No
Primary Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550 Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state. 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 No
Primary Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550 Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state. 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29 No
Primary Maximum Observed Plasma Concentration (Cmax) For CP-690,550 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 No
Primary Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 No
Primary Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 No
Primary Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 No
Primary Accumulation Ratio (Rac) For CP-690,550 Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1). 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29 No
Primary Plasma Decay Half-Life (t1/2) For CP-690,550 Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 No
Primary Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550 Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state. 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29 No
Primary Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. Screening, 0 hour (pre-dose) on Day 1 No
Primary Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8 Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 8 No
Primary Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15 Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 15 No
Primary Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29 Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 29 No
Primary Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57 Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 57 No
Primary Cyclosporine (CsA) Plasma Trough Concentration at Baseline The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. Screening, 0 hour (pre-dose) on Day 1 No
Primary Cyclosporine (CsA) Plasma Trough Concentration at Day 8 CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 8 No
Primary Cyclosporine (CsA) Plasma Trough Concentration at Day 15 CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 15 No
Primary Cyclosporine (CsA) Plasma Trough Concentration at Day 29 CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 29 No
Primary Cyclosporine (CsA) Plasma Trough Concentration at Day 57 CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 57 No
Primary Tacrolimus (TAC) Plasma Trough Concentration at Baseline The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. Screening, 0 hour (pre-dose) on Day 1 No
Primary Tacrolimus (TAC) Plasma Trough Concentration at Day 8 TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 8 No
Primary Tacrolimus (TAC) Plasma Trough Concentration at Day 15 TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 15 No
Primary Tacrolimus (TAC) Plasma Trough Concentration at Day 29 TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 29 No
Primary Tacrolimus (TAC) Plasma Trough Concentration at Day 57 TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure. 0 hour (pre-dose) on Day 57 No
See also
  Status Clinical Trial Phase
Completed NCT04087720 - Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant Phase 4
Completed NCT03749356 - Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients Phase 4
Withdrawn NCT05811468 - Study Correlation Between Blood, Tissue Gene Expression, Donor Derived Cell Free DNA and Histopathology in Kidney Transplant Recipients
Completed NCT03527238 - Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine Phase 2
Completed NCT00498576 - Melatonin and Adiponectin in Hypertensive Kidney Transplant N/A
Completed NCT00642655 - Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation Phase 1/Phase 2
Completed NCT00374400 - The Paired Donation Consortium Paired Donation Program N/A
Completed NCT00205257 - Prediction of Acute Rejection in Renal Transplant Phase 1
Completed NCT02711826 - Treg Therapy in Subclinical Inflammation in Kidney Transplantation Phase 1/Phase 2
Withdrawn NCT03978494 - Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients. Phase 1
Completed NCT03837522 - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies N/A
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT05029310 - Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients Phase 4
Completed NCT03644485 - Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients Phase 4
Active, not recruiting NCT02409901 - Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients N/A
Completed NCT01047410 - ACtive Care After Transplantation, the ACT Study N/A
Completed NCT00940940 - Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation Phase 4
Completed NCT00217126 - The Study of Long-term Deterioration of Kidney Transplants. Phase 4
Completed NCT00270712 - A Study of Factors That Affect Long-Term Kidney Transplant Function
Completed NCT00171496 - Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients Phase 4