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 range18 Years
SexALL
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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…
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)