Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multicenter Study In Patients With Type 2 Diabetes And Persistent Albuminuria To Evaluate The Safety And Efficacy Of A Six Month Regimen Of Orally-Administered TTP488

Pfizer1 site in 1 country110 target enrollmentFebruary 2006

ConditionsDiabetic Nephropathy

InterventionsPF-04494700 (TTP488)Placebo

DrugsPF-04494700 (TTP488)

Overview

Phase: Phase 2
Intervention: PF-04494700 (TTP488)
Conditions: Diabetic Nephropathy
Sponsor: Pfizer
Enrollment: 110
Locations: 1
Primary Endpoint: Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Current research indicates that TTP488 may be a viable agent for the treatment of diabetic nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month regimen of daily orally-administered TTP488 to patients with diabetic nephropathy.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

August 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Eligibility Criteria

Inclusion Criteria

•Male or female outpatients 31 years of age or older.
•Females must no longer be of child-bearing potential, must have a negative serum pregnancy test, and cannot be breast-feeding.
•Non-vasectomized male must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception.
•Diagnosis of probable Type 2 diabetes after the age of 30 and for at least 6 months prior to the screening visit and: not requiring insulin within first year of diagnosis; no history of diabetic ketoacidosis (DKA); body mass index (BMI) of 40 or less at the screening visit
•Presence of persistent albuminuria with a UACR of 6.7 - 203 mg/mmol Must be taking the highest tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and have been maintained on that dose for at least 3 months prior to the Baseline visit
•Blood pressure(BP) must be stable and well controlled by the judgement of the investigator (goal of the control of BP is 130/80 or less). If required, the use of anti-hypertensives in addition to an ACE inhibitor or an ARB is acceptable.
•Patients with a calculated creatinine clearance of greater than or equal to 30 mL/min and without the presence of clinically significant hematuria or red or white cell casts can be included in the study.

Exclusion Criteria

•Diagnosis of Type 1 diabetes
•Hemoglobin A1c (HbA1c) \>10%
•Females cannot be breast-feeding
•Known renal artery stenosis
•Calculated creatinine clearance \<30 mL/min or the presence of clinically significant hematuria of red or white cell casts
•Chronic use of NSAIDs or more than 1 g/day of aspirin
•QTc \>450 msec for females or \>430 msec for males (a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle)
•Known family history of prolonged QT syndrome
•History of symptomatic congestive heart failure within the last 2 years
•History of syncope in the lst 2 years or recurrent hypokalemia, including that caused by diuretics

Arms & Interventions

PF-04494700 (TTP488)

Intervention: PF-04494700 (TTP488)

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR)

Time Frame: from baseline to end of treatment (Month 6).

Secondary Outcomes

To evaluate treatment on estimated GFR and serum creatinine(evaluated for change from baseline to months 3 & 6)
To evaluate the effects of TTP488 on other relevant biomarkers(evaluated at months 1, 3 & 6)
To evaluate the safety of TTP488(Ongoing)
To evaluate the PK profile of oral TTP488.(Ongoing)
To evaluate the effect of treatment with TTP488 on UACR(evaluated from baseline to month 3 visit)