A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

This study is currently recruiting participants.
Verified August 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200394
First received: September 10, 2010
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.


Condition Intervention Phase
Diabetic Nephropathies
Drug: PF-00489791
Drug: 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: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Evaluate The Efficacy And Safety Of Once-Daily Administration Of A Phosphodiesterase 5 Inhibitor (PF-00489791) In Adults With Type 2 Diabetes And Overt Nephropathy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Urine albumin: creatinine ratio (UACR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine albumin: creatinine ratio at 3, 6 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Urine protein: creatinine ratio at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Systolic, diastolic and mean arterial blood pressure at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum creatinine at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Urinary TGFbeta1 at Weeks 3, 6, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum C-reactive protein (hs-CRP) at Weeks 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum cystatin C at Weeks 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • An assessment of the pharmacokinetic parameters of PF-00489791. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Plasma glycosylated hemoglobin (HbA1c). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Safety and tolerability measures (AEs, clinical laboratory assessments, physical examination including weight, worsening of edema, increased use of diuretics). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: October 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00489791 Drug: PF-00489791
Tablet, 20 mg once daily for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Tablet, placebo once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
  • Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
  • Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.

Exclusion Criteria:

  • Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
  • Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.
  • Subjects on combination ACE inhibitor/ARB therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200394

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 135 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01200394     History of Changes
Other Study ID Numbers: A7331011
Study First Received: September 10, 2010
Last Updated: August 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Diabetic nephropathy
chronic kidney disease
PF-00489791
phosphodiesterase
PDE5

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014