Phase 2
N=256
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Diabetic Nephropathies
Bottom Line
View on ClinicalTrials.gov: NCT01200394 ↗Enrolled (actual)
256
Serious AEs
7.4%
Results posted
Mar 2019
Primary outcome: Primary: Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12 — 195.130; 182.378; 9.072; -6.539 mg/mmol — p=0.9889
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-00489791 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12 |
195.130; 182.378; 9.072; -6.539 | 0.9889 |
| SECONDARY Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16 |
-11.805; -14.268; -7.772; -2.546; 16.500; 2.802 | 0.0382 sig |
| SECONDARY Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16 |
282.208; 261.015; -20.302; -26.883; -10.278; 10.699 | 0.0297 sig |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16 |
38.575; 37.740; 0.069; -0.156; -0.930; -0.755 | 0.3585 |
| SECONDARY Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16 |
137.20; 131.81; 76.98; 73.27; 107.27; 102.68 | <0.0001 sig |
| SECONDARY Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16 |
164.929; 163.637; 1.232; 2.691; 3.158; 4.974 | — |
| SECONDARY Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16 |
177.88; 213.37; -22.81; -54.06; 23.33; -68.59 | 0.5422 |
| SECONDARY Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16 |
3.019; 4.330; 1.183; 0.106; 0.317; -0.102 | — |
| SECONDARY Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16 |
1.659; 1.695; 0.096; 0.070; 0.104; 0.075 | — |
| SECONDARY Plasma Concentration Versus Time Summary of PF-00489791 |
0.6540; 0.4156; 0.9772; 0.3514; 0.9274; 0.3930 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01200394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.