A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

Phase 1

Terminated

• Conditions: Type 2 Diabetic Nephropathy
• Interventions: Drug: Spironolactone; Other: placebo; Drug: PF-03882845

• Registration Number: NCT01488877
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Study Start: 2012-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-07-18
• Results First Submitted QC: 2013-07-18
• Status Verified: 2013-09
• Results First Posted: 2013-09-23
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spironolactone	Spironolactone	25 mg once daily
Placebo	placebo	Placebo once daily
PF03882845	PF-03882845	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Serum Potassium at Day 8	Baseline, Day 7, 8	Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.
Change From Baseline in Serum Potassium at Day 15	Baseline, Day 14, 15	Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.
Number of Participants With Confirmed and Severe Hyperkalemia	Baseline up to Day 15	Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (\>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level \>= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.

Secondary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetic (PK) Parameters	0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14	PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.
Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15	Day 1 (Baseline), 15	Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.
Change From Baseline in Sitting Pulse Rate at Day 15	Day 1 (Baseline), 15	Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New York, New York, United States