A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetic Nephropathy

Treatments: Drug: PF-03882845; Other: placebo; Drug: Spironolactone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01488877

B0171011

Details and patient eligibility

About

PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.

Full description

This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.

Enrollment: 6 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and/or Females between 18-65 years, inclusive.
• Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
• Have type 2 diabetes mellitus.
• On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.

Exclusion criteria

• Recent evidence or medical history of unstable concurrent disease.
• Cardiovascular event within 3 months prior to screening.
• History of renal transplant.
• History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

6 participants in 3 patient groups, including a placebo group

PF03882845

Experimental group

Treatment:

Drug: PF-03882845

Drug: PF-03882845

Drug: PF-03882845

Spironolactone

Active Comparator group

Description:

25 mg once daily

Treatment:

Drug: Spironolactone

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Other: placebo