Clinical trial NCT01710033: A Study Of CP-690,550 In Stable Kidney Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Transplant
Keywords: CP-690,550
kidney transplant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-10-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
measure: Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29
measure: Maximum Observed Plasma Concentration (Cmax) For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
measure: Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
measure: Accumulation Ratio (Rac) For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29
measure: Plasma Decay Half-Life (t1/2) For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1
measure: Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550
timeFrame: 0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline
timeFrame: Screening, 0 hour (pre-dose) on Day 1
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8
timeFrame: 0 hour (pre-dose) on Day 8
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15
timeFrame: 0 hour (pre-dose) on Day 15
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29
timeFrame: 0 hour (pre-dose) on Day 29
measure: Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57
timeFrame: 0 hour (pre-dose) on Day 57
measure: Cyclosporine (CsA) Plasma Trough Concentration at Baseline
timeFrame: Screening, 0 hour (pre-dose) on Day 1
measure: Cyclosporine (CsA) Plasma Trough Concentration at Day 8
timeFrame: 0 hour (pre-dose) on Day 8
measure: Cyclosporine (CsA) Plasma Trough Concentration at Day 15
timeFrame: 0 hour (pre-dose) on Day 15
measure: Cyclosporine (CsA) Plasma Trough Concentration at Day 29
timeFrame: 0 hour (pre-dose) on Day 29
measure: Cyclosporine (CsA) Plasma Trough Concentration at Day 57
timeFrame: 0 hour (pre-dose) on Day 57
measure: Tacrolimus (TAC) Plasma Trough Concentration at Baseline
timeFrame: Screening, 0 hour (pre-dose) on Day 1
measure: Tacrolimus (TAC) Plasma Trough Concentration at Day 8
timeFrame: 0 hour (pre-dose) on Day 8
measure: Tacrolimus (TAC) Plasma Trough Concentration at Day 15
timeFrame: 0 hour (pre-dose) on Day 15
measure: Tacrolimus (TAC) Plasma Trough Concentration at Day 29
timeFrame: 0 hour (pre-dose) on Day 29
measure: Tacrolimus (TAC) Plasma Trough Concentration at Day 57
timeFrame: 0 hour (pre-dose) on Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Livingston
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: