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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01488877
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : December 8, 2011
Results First Posted : September 23, 2013
Last Update Posted : October 29, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Type 2 Diabetic Nephropathy
Interventions: Drug: PF-03882845
Drug: Spironolactone
Other: placebo

  Participant Flow

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Entire Study Population All participants who were enrolled in this study.

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
Age, Customized 
[Units: Participants]
less than (<) 18 years   0 
18 to 44 years   0 
45 to 64 years   6 
greater than or equal to (>=) 65 years   0 
[Units: Participants]
Female   3 
Male   3 

  Outcome Measures

1.  Primary:   Change From Baseline in Serum Potassium at Day 8   [ Time Frame: Baseline, Day 7, 8 ]

2.  Primary:   Change From Baseline in Serum Potassium at Day 15   [ Time Frame: Baseline, Day 14, 15 ]

3.  Primary:   Number of Participants With Confirmed and Severe Hyperkalemia   [ Time Frame: Baseline up to Day 15 ]

4.  Secondary:   Plasma Pharmacokinetic (PK) Parameters   [ Time Frame: 0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14 ]

5.  Secondary:   Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15   [ Time Frame: Day 1 (Baseline), 15 ]

6.  Secondary:   Change From Baseline in Sitting Pulse Rate at Day 15   [ Time Frame: Day 1 (Baseline), 15 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated prematurely; this was based on a strategic decision by the sponsor to terminate further development of this compound for proposed indication. The study was not terminated for safety or lack of efficacy reasons.

  More Information