Study Stopped
See termination reason in detailed description.
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
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
1 other identifier
interventional
6
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2012
Shorter than P25 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2011
CompletedFirst Posted
Study publicly available on registry
December 8, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
September 23, 2013
CompletedOctober 29, 2013
September 1, 2013
6 months
December 6, 2011
July 18, 2013
September 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in Serum Potassium at Day 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.
Baseline, Day 7, 8
Change From Baseline in Serum Potassium at Day 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.
Baseline, Day 14, 15
Number of Participants With Confirmed and Severe Hyperkalemia
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.
Baseline up to Day 15
Secondary Outcomes (3)
Plasma Pharmacokinetic (PK) Parameters
0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14
Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15
Day 1 (Baseline), 15
Change From Baseline in Sitting Pulse Rate at Day 15
Day 1 (Baseline), 15
Study Arms (3)
PF03882845
EXPERIMENTALSpironolactone
ACTIVE COMPARATOR25 mg once daily
Placebo
PLACEBO COMPARATORPlacebo once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (6)
Pfizer Investigational Site
Chula Vista, California, 91911, United States
Pfizer Investigational Site
San Diego, California, 92123, United States
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Pfizer Investigational Site
Miami, Florida, 33169, United States
Pfizer Investigational Site
Kalamazoo, Michigan, 49007, United States
Pfizer Investigational Site
New York, New York, 10019, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2011
First Posted
December 8, 2011
Study Start
January 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
October 29, 2013
Results First Posted
September 23, 2013
Record last verified: 2013-09