Clinical trial NCT01488877: A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
Official title: A 2-week, Phase 1b, Randomized, Double-Blind, Placebo- Controlled, Multi-Dose, Dose-Escalating Study With PF-03882845 And One Dose Of Spironolactone To Evaluate Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Subjects With Type 2 Diabetes Mellitus And Albuminuria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetic Nephropathy
Keywords: Type 2 diabetes mellitus. albuminuria.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.

Detailed description: This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.

Eligibility criteria: Inclusion Criteria:

* Males and/or Females between 18-65 years, inclusive.
* Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
* Have type 2 diabetes mellitus.
* On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.

Exclusion Criteria:

* Recent evidence or medical history of unstable concurrent disease.
* Cardiovascular event within 3 months prior to screening.
* History of renal transplant.
* History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.

Primary outcomes:
measure: Change From Baseline in Serum Potassium at Day 8
timeFrame: Baseline, Day 7, 8
measure: Change From Baseline in Serum Potassium at Day 15
timeFrame: Baseline, Day 14, 15
measure: Number of Participants With Confirmed and Severe Hyperkalemia
timeFrame: Baseline up to Day 15
Secondary outcomes:
measure: Plasma Pharmacokinetic (PK) Parameters
timeFrame: 0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14
measure: Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15
timeFrame: Day 1 (Baseline), 15
measure: Change From Baseline in Sitting Pulse Rate at Day 15
timeFrame: Day 1 (Baseline), 15
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: