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Also known as KW-3902IV, MK7418
rolofylline · 6 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 2 | PLACEBO_COMPARATOR | placebo control |
| 1 | EXPERIMENTAL | KW-3902IV |
| Name | Type | Description |
|---|---|---|
| rolofylline | DRUG | rolofylline 30 mg IV QD; 3 days |
| Comparator: Placebo (unspecified) | DRUG | rolofylline Pbo 30 mg IV QD; 3 days |
| Comparator: Placebo | DRUG | rolofylline placebo IV infusion over 4 hours. |
| KW-3902IV | DRUG | - |
Inclusion Criteria: * Dyspnea at rest or with minimal exertion at randomization * Fluid overload * Estimated creatinine clearance (CrCl) between 20-60 mL/min * Worsening renal function * Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug * BNP \>500 pg/mL...
Rolofylline is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK) for heart failure and congestive heart failure. It was studied in hospitalized patients with acute heart failure and volume overload, and in patients with worsening renal function. It is not an approved therapy and remains in clinical development.
Rolofylline targets ADORA1, the adenosine A1 receptor, and acts as an antagonist. By blocking this receptor, the drug was designed to influence hemodynamics and renal function in patients with heart failure. This mechanism was the basis for its study in acute heart failure with volume overload.
Rolofylline was developed by Merck & Company, Inc., which trades under the ticker MRK. The compound is also known by the code KW-3902, which appears in several of its clinical trial titles. Merck sponsored the clinical program evaluating the drug in heart failure.
Rolofylline is investigational and has been studied in Phase 2 and Phase 3 clinical trials. The program includes a completed Phase 2 hemodynamic study and three completed Phase 3 trials in heart failure. There are no active trials, and the drug is not approved for any indication.
Rolofylline has been evaluated in completed trials including NCT00729222, a Phase 2 hemodynamic study in heart failure; NCT00443690, a Phase 3 placebo-controlled study in worsening renal function and heart failure; and the Phase 3 PROTECT-1 (NCT00328692) and PROTECT-2 (NCT00354458) trials in acute heart failure with volume overload.
Yes, rolofylline is also known as KW-3902. The code KW-3902 appears in the titles of its clinical trials, including the PROTECT-1 and PROTECT-2 Phase 3 studies and the Phase 3 study in worsening renal function. Both names refer to the same adenosine A1 receptor antagonist developed by Merck.