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KW-3902IV

Phase 3

Heart Failure, Congestive | Small molecule | Cardiovascular |Merck & Company, Inc.|Trials Updated: Oct 20, 2015

KW-3902IV development status

Highest phase Phase 3 (NCT00354458)
Phase scored for MRKPhase 2
Registered trials 6 across 2 sponsors since Sep 2005

KW-3902IV target and mechanism

ModalitySmall molecule

Also known as rolofylline, MK7418

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials6
Total Enrollment2,656

FDA Designations

No designations recorded

KW-3902IV clinical trials

KW-3902IV · 6 trials · 3 indications

Phase 3 3Phase 2 3
NCT00443690Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV TherapyHeart Failure, Congestive
COMPLETED480 Analytics
NCT00354458PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal FunctionHeart Failure, Congestive
COMPLETED1,102 Analytics
NCT00328692PROTECT-1: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal FunctionHeart Failure, Congestive
COMPLETED932 Analytics
PHASE3COMPLETED
Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV Therapy
Heart Failure, Congestive
NCT00443690480
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PHASE3COMPLETED
PROTECT-2: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
Heart Failure, Congestive
NCT003544581,102
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PHASE3COMPLETED
PROTECT-1: A Study of the Selective A1 Adenosine Receptor Antagonist KW-3902 for Patients Hospitalized With Acute HF and Volume Overload to Assess Treatment Effect on Congestion and Renal Function
Heart Failure, Congestive
NCT00328692932
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Study Endpoints

Primary Endpoints

Effect on heart failure signs and symptoms
through day 7
Effect on renal function
through Day 7
change in pulmonary capillary wedge pressure
from baseline to 4 and 8 hours
Comparison of KW-3902IV alone or with loop diuretic on renal function.
Change in urine volume from baseline

Secondary Endpoints

safety
3 Days
within trial medical costs compared to placebo
3 Days
Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure
from baseline to 4 and 8 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2PLACEBO_COMPARATORplacebo control
1EXPERIMENTALKW-3902IV

Interventions

NameTypeDescription
rolofyllineDRUGrolofylline 30 mg IV QD; 3 days
Comparator: Placebo (unspecified)DRUGrolofylline Pbo 30 mg IV QD; 3 days
Comparator: PlaceboDRUGrolofylline placebo IV infusion over 4 hours.
KW-3902IVDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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...

Countries:United States
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Frequently asked questions about KW-3902IV

What is KW-3902IV used for in congestive heart failure?

KW-3902IV is an investigational small molecule being studied in patients with congestive heart failure. It was evaluated in Phase 2 clinical trials for its effects on diuresis and on renal function when given with intravenous furosemide in patients who have heart failure and renal impairment.

Who is developing KW-3902IV?

KW-3902IV is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the clinical program evaluating this investigational small molecule in patients with congestive heart failure.

What phase is KW-3902IV in?

KW-3902IV is in Phase 2 clinical development. Two Phase 2 trials have been completed, and there are currently no active trials listed for this investigational drug. It has not been approved by the FDA and remains an investigational therapy for congestive heart failure.

What clinical trials is KW-3902IV in?

KW-3902IV has been studied in two completed Phase 2 trials. NCT00159627 was a dose escalation study of KW-3902 on diuresis in subjects with congestive heart failure, enrolling 52 patients. NCT00159614 evaluated KW-3902IV in combination with IV furosemide on renal function in subjects with CHF and renal impairment, enrolling 30 patients.

How many patients were enrolled in KW-3902IV trials?

A total of 82 patients were enrolled across the two completed Phase 2 trials of KW-3902IV. NCT00159627 enrolled 52 patients, and NCT00159614 enrolled 30 patients. Both trials were randomized and double-blind and were conducted in the United States.

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