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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathies

Treatments: Drug: PF-00489791; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01200394

A7331011

2010-021358-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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256 participants in 2 patient groups, including a placebo group

PF-00489791

Experimental group

Treatment:

Drug: PF-00489791

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo