NCT00287183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Typical duration for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

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

January 20, 2006

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

3.5 years

First QC Date

January 20, 2006

Last Update Submit

September 30, 2009

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

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

    from baseline to end of treatment (Month 6).

Secondary Outcomes (5)

  • 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

Study Arms (2)

PF-04494700 (TTP488)

ACTIVE COMPARATOR
Drug: PF-04494700 (TTP488)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

PF-04494700 (TTP488)DRUG

60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication

PF-04494700 (TTP488)
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age31 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Myocardial infarction or signs or symptoms of unstable coronary artery disease with the last year
  • Pulmonary disease or evidence of clinically significant pulmonary symptoms.
  • Active neoplastic disease. (Excised cutaneous basal cell carcinomas are not excluded). Patients with stable prostate cancer may be included at the discretion of the Medical Monitor.
  • Any clinically significant hematologic or coagulation disorder
  • Any clinically significant hepatic disease
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Pfizer Investigational Site

Red Deer, Alberta, T4N 6V7, Canada

Location

Pfizer Investigational Site

Penticton, British Columbia, V2A 5C8, Canada

Location

Pfizer Investigational Site

Vancouver, British Columbia, V6E 1M7, Canada

Location

Pfizer Investigational Site

Burlington, Ontario, L7M 4Y1, Canada

Location

Pfizer Investigational Site

Courtice, Ontario, L1E 3C3, Canada

Location

Pfizer Investigational Site

Fort Erie, Ontario, L2A 1Z3, Canada

Location

Pfizer Investigational Site

Hamilton, Ontario, L8M 1K7, Canada

Location

Pfizer Investigational Site

Kitchener, Ontario, N2G 1N9, Canada

Location

Pfizer Investigational Site

Kitchener, Ontario, N2H 5Z8, Canada

Location

Pfizer Investigational Site

Millon, Ontario, L9T 0H7, Canada

Location

Pfizer Investigational Site

North Bay, Ontario, P1B 2H3, Canada

Location

Pfizer Investigational Site

Oakville, Ontario, L6H 3P1, Canada

Location

Pfizer Investigational Site

Saint Catherines, Ontario, L2N 7H8, Canada

Location

Pfizer Investigational Site

Scarborough Village, Ontario, M1H 3G4, Canada

Location

Pfizer Investigational Site

Smith Falls, Ontario, K7A 4W8, Canada

Location

Pfizer Investigational Site

Thornhill, Ontario, L4J 8L7, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M4N-3M5, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M4R 2G4, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Related Links

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

azeliragon

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 20, 2006

First Posted

February 6, 2006

Study Start

February 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

CA(19)