Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Fun… (NCT00443690) | Clinical Trial Compass
CompletedPhase 3
Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV Therapy
480 participantsStarted 2007-08
Plain-language summary
To evaluate the effect of KW-3902IV, in addition to standard therapy, on the proportion of worsening heart failure and worsening renal function, and on the proportion of deaths or rehospitalizations for heart failure or worsening renal function, and to estimate and compare within-trial medical resource utilization and direct medical costs between subjects treated with KW 3902IV versus placebo.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 or NT-pro-BNP \>2000 pg/mL
* Systolic blood pressure ≥90 mmHg at randomization
Exclusion Criteria:
* IV radiographic contrast within 14 days
* IV vasodilators within 6 hours
* Serum potassium \<3.5 meq/L
* Ongoing or planned therapy for heart failure with mechanical circulatory or ventilatory support
* Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis
* Rapidly progressive acute renal failure
* Evidence of acute tubular necrosis or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure
* Severe pulmonary disease
* Significant stenotic mitral or aortic valvular disease
* Heart transplant recipient or admitted for cardiac transplantation or LVAD surgery
* Any major surgery within 2 weeks prior
* evidence of acute coronary syndrome in the 2 weeks prior
* Hgb \<8 g/dL, Hct \<25%, or active bleeding requiring transfusion
* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.
* Known hepatic impairment
* Non-cardiac pulmonary edema
* Temperature \>38°C
* Sepsis or active infection requiring IV anti-microbial treatment
* Administration of an investigational drug or dev…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect on heart failure signs and symptoms
Timeframe: through day 7
2
Effect on renal function
Timeframe: through Day 7
Trial details
NCT IDNCT00443690
SponsorNovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)