A Study Of CP-690,550 In Stable Kidney Transplant Patients

Kidney Transplant Clinical Trial

Official title:

Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01710033
• Other study ID #: A3921007
• 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

• Kidney Transplant

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

External Links

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