Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04634817 · 2 trials · 2 indications
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
AUC (0 - 48)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 48hours.
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
| Arm | Type | Description |
|---|---|---|
| Arm 1 PF-04634817 | ACTIVE_COMPARATOR | - |
| Arm 2 Placebo | PLACEBO_COMPARATOR | - |
| Healthy Volunteers | EXPERIMENTAL | - |
| Mild Renal Impairment | EXPERIMENTAL | - |
| Moderate renal impairment | EXPERIMENTAL | - |
| Severe renal impairment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-04634817 | DRUG | Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function |
| Placebo | DRUG | Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function |
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 ...
Top 3 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | ALN-ANG3, Evinacumab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| ProKidney Corp. Class A | PROK | 2 | - | Rilparencel |
PF-04634817 was studied for diabetic nephropathy, a kidney complication of type 2 diabetes, and for renal insufficiency. It is an investigational small molecule developed by Pfizer that was evaluated in a Phase 2 trial in adults with type 2 diabetes and overt nephropathy, and in a Phase 1 study in people with renal impairment.
PF-04634817 targets CCR2 and CCR5, two chemokine receptors. It acts as an antagonist, meaning it blocks signaling through these receptors. This mechanism was being explored in the setting of kidney disease associated with type 2 diabetes.
PF-04634817 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the clinical program evaluating the compound in diabetic nephropathy and renal insufficiency.
PF-04634817 is in Phase 2 development. It is an investigational agent and has not been approved by the FDA. The Phase 2 study in diabetic nephropathy has been completed, and no trials of the drug are currently active.
PF-04634817 has been studied in two completed trials. NCT01712061 was a Phase 2, multi-center, randomized, double-blind, placebo-controlled study in 226 adults with type 2 diabetes and overt nephropathy. NCT01791855 was a Phase 1 renal impairment study in 32 participants in the United States.
NCT01712061 was a Phase 2, multi-center, randomized, double-blind, placebo-controlled study of PF-04634817 in adults with type 2 diabetes and overt nephropathy. It enrolled 226 participants across the United States, Argentina, Australia, Canada, Germany, Hong Kong, Italy, Malaysia, Peru, Poland, Puerto Rico, Romania, South Korea, and Spain. The trial has been completed.