6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00287183
First received: January 20, 2006
Last updated: September 30, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
Drug: PF-04494700 (TTP488)
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate treatment on estimated GFR and serum creatinine [ Time Frame: evaluated for change from baseline to months 3 & 6 ] [ Designated as safety issue: No ]
  • To evaluate the effects of TTP488 on other relevant biomarkers [ Time Frame: evaluated at months 1, 3 & 6 ] [ Designated as safety issue: No ]
  • To evaluate the safety of TTP488 [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • To evaluate the PK profile of oral TTP488. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • To evaluate the effect of treatment with TTP488 on UACR [ Time Frame: evaluated from baseline to month 3 visit ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: February 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PF-04494700 (TTP488) Drug: PF-04494700 (TTP488)
60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
Placebo Comparator: Placebo Other: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   31 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  • Use of excluded medications: drugs known to significantly increase QTc and/or have increased risk of torsades de point, immunosuppressive agents, cancer chemotherapeutic agents, oral corticosteroids other than maintenance doses equivalent to 7.5 mg prednisone per day, and radiotherapy
  • Use of an investigational drug within 30 days or within 5 half-lives of the investigational agent, whichever is longer, or use of an investigational medical device within 2 weeks before or after the study
  • Any other disease or condition that, in the opinion of the investigator, makes the patient unsuitable to participate in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287183

Locations
Canada, Alberta
Pfizer Investigational Site
Red Deer, Alberta, Canada, T4N 6V7
Canada, British Columbia
Pfizer Investigational Site
Penticton, British Columbia, Canada, V2A 5C8
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Ontario
Pfizer Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Pfizer Investigational Site
Courtice, Ontario, Canada, L1E 3C3
Pfizer Investigational Site
Fort Erie, Ontario, Canada, L2A 1Z3
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
Pfizer Investigational Site
Kitchener, Ontario, Canada, N2G 1N9
Pfizer Investigational Site
Kitchener, Ontario, Canada, N2H 5Z8
Pfizer Investigational Site
Millon, Ontario, Canada, L9T 0H7
Pfizer Investigational Site
North Bay, Ontario, Canada, P1B 2H3
Pfizer Investigational Site
Oakville, Ontario, Canada, L6H 3P1
Pfizer Investigational Site
Saint Catherines, Ontario, Canada, L2N 7H8
Pfizer Investigational Site
Scarborough, Ontario, Canada, M1H 3G4
Pfizer Investigational Site
Smith Falls, Ontario, Canada, K7A 4W8
Pfizer Investigational Site
Thornhill, Ontario, Canada, L4J 8L7
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N-3M5
Pfizer Investigational Site
Toronto, Ontario, Canada, M4R 2G4
Canada, Saskatchewan
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 0H6
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00287183     History of Changes
Other Study ID Numbers: B0341001, TTP488-202
Study First Received: January 20, 2006
Last Updated: September 30, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on August 26, 2014