Phase 2
N=226
A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy
Diabetic Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT01712061 ↗Enrolled (actual)
226
Serious AEs
9.7%
Results posted
Oct 2015
Primary outcome: Primary: Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12 — 13.27; 5.02 percent (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PF-04634817 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12 |
13.27; 5.02 | — |
| SECONDARY Change From Baseline in UACR at Weeks 4, 8 and 16 |
127.41; 121.80; 0.89; 0.91; 0.90; 0.94 | — |
| SECONDARY Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16 |
185.42; 176.31; 0.93; 0.92; 0.92; 0.94 | — |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16 |
41.80; 41.65; -0.77; -0.35; -1.07; -1.32 | — |
| SECONDARY Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16 |
45.28; 45.36; -1.10; -0.70; -2.27; -0.91 | — |
| SECONDARY Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 |
1.72; 1.77; 0.05; 0.03; 0.06; 0.11 | — |
| SECONDARY Change From Baseline in Serum Cystatin C at Weeks 12 and 16 |
1.54; 1.52; 0.03; 0.03; 0.05; 0.06 | — |
| SECONDARY Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16 |
7.51; 7.91; 0.03; -0.04; -0.02; -0.08 | — |
| SECONDARY Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12 |
434.5; 524.4; 579.3; 602.9; 497.4; 547.7 | — |
Summary
The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2.
- Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9 mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.
- Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.
Exclusion Criteria
- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.
Data sourced from ClinicalTrials.gov (NCT01712061). 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.