Safety and Efficacy Study to Evaluate the Effect of SLV320 on Renal Function in Patients With Worsening Heart Failure

NCT00744341 | Terminated Phase 2 DMC

• 3 other identifiers: S320.2.0112008-003786-2000744341
• Study Type: interventional
• Target: 46
• Locations: 11 countries
• Sites: 105

Brief Summary

The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

Conditions

Acute Decompensated Heart Failure; Renal Dysfunction

Keywords

SLV320; Acute Decompensated Heart Failure (ADHF); chronic heart failure; renal failure; I.V. doses; hospitalization

Outcome Measures

Primary Outcomes (1)

• Change in serum creatinine from baseline to Day 14

  Day 14

Secondary Outcomes (5)

• To compare four SLV320 doses to placebo on the change in the following variables: Dyspnea (Likert Scale and PDA scale), eGFR (MDRD Formula), Subject Global Clinical Assessment Score, Urine Osmolality, Serum Osmolality

  Up to Day 3 (Dyspnea); Up to Day 4 (Urine Osmolality); Up to Day 60 (eGFR, Subject Global Clinical Assessment Score, Serum Osmolality)

• To compare the effect of four I.V. doses of SLV320 with placebo using the trichotomous endpoint of treatment success, treatment failure, or no change

  Up to Day 14

• To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use

  Up to Day 3

• To compare the effect of four I.V. doses of SLV320 with placebo using a composite endpoint of all-cause mortality, cardiovascular hospitalization or hospitalization for worsening renal function, in time to event and frequency

  Up to Day 180

• To determine the pharmacokinetic profile of I.V. SLV320

  Up to Day 3

Study Arms (5)

1

EXPERIMENTAL

Drug: SLV320

2

EXPERIMENTAL

Drug: SLV320

3

EXPERIMENTAL

Drug: SLV320

4

EXPERIMENTAL

Drug: SLV320

5

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SLV320 DRUG

1.25mg i.v. bid

1

Placebo DRUG

5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Solvay Pharmaceuticals: lead

Study Sites (105)

S320.2.011 Site # 548

Alameda, California, United States

Location

S320.2.011 Site # 566

Banning, California, United States

Location

S320.2.011 Site # 551

Inglewood, California, United States

Location

S320.2.011 Site # 564

Bridgeport, Connecticut, United States

Location

S320.2.011 Site # 505

Hollywood, Florida, United States

Location

S320.2.011 Site # 507

Jacksonville, Florida, United States

Location

S320.2.011 Site # 532

Riverdale, Georgia, United States

Location

S320.2.011 Site # 513

Chicago, Illinois, United States

Location

S320.2.011 Site # 561

Indianapolis, Indiana, United States

Location

S320.2.011 Site # 526

Owensboro, Kentucky, United States

Location

S320.2.011 Site # 504

Natchitoches, Louisiana, United States

Location

S320.2.011 Site # 546

Biddeford, Maine, United States

Location

S320.2.011 Site # 523

Dearborn, Michigan, United States

Location

S320.2.011 Site # 534

Detroit, Michigan, United States

Location

S320.2.011 Site # 558

Detroit, Michigan, United States

Location

S320.2.011 Site # 508

St Louis, Missouri, United States

Location

S320.2.011 Site # 541

Brooklyn, New York, United States

Location

S320.2.011 Site # 537

New York, New York, United States

Location

S320.2.011 Site # 521

Akron, Ohio, United States

Location

S320.2.011 Site # 527

Toledo, Ohio, United States

Location

S320.2.011 Site # 528

Philadelphia, Pennsylvania, United States

Location

S320.2.011 Site # 510

Colombia, South Carolina, United States

Location

S320.2.011 Site # 545

Nashville, Tennessee, United States

Location

S320.2.011 Site # 519

Tullahoma, Tennessee, United States

Location

S320.2.011 Site # 511

Houston, Texas, United States

Location

S320.2.011 Site # 518

San Antonio, Texas, United States

Location

S320.2.011 Site # 556

Manitowoc, Wisconsin, United States

Location

S320.2.011 Site # 565

Milwaukee, Wisconsin, United States

Location

S320.2.011 Site # 601

Montreal, Canada

Location

S320.2.011 Site # 427

Santiago, Chile

Location

S320.2.011 Site # 433

Viña del Mar, Chile

Location

S320.2.011 Site # 434

Viña del Mar, Chile

Location

S320.2.011 Site # 100

Aarhus, Denmark

Location

S320.2.011 Site # 102

Aarhus, Denmark

Location

S320.2.011 Site # 104

Copenhagen, Denmark

Location

S320.2.011 Site # 103

Esbjerg, Denmark

Location

S320.2.011 Site # 106

Frederiksberg, Denmark

Location

S320.2.011 Site # 105

Herning, Denmark

Location

S320.2.011 Site # 125

Dijon, France

Location

S320.2.011 Site # 123

Lille, France

Location

S320.2.011 Site # 121

Paris, France

Location

S320.2.011 Site # 124

Pessac, France

Location

S320.2.011 Site # 126

Pontoise, France

Location

S320.2.011 Site # 128

Toulouse, France

Location

S320.2.011 Site # 182

Bad Nauheim, Germany

Location

S320.2.011 Site # 187

Berlin, Germany

Location

S320.2.011 Site # 186

Frankfurt, Germany

Location

S320.2.011 Site # 180

Hanover, Germany

Location

S320.2.011 Site # 185

Limburg, Germany

Location

S320.2.011 Site # 190

Mannheim, Germany

Location

S320.2.011 Site # 188

Weiden, Germany

Location

S320.2.011 Site # 146

Aosta, Italy

Location

S320.2.011 Site # 145

Cremona, Italy

Location

S320.2.011 Site # 142

Genova, Italy

Location

S320.2.011 Site # 149

Milan, Italy

Location

S320.2.011 Site # 140

Modena, Italy

Location

S320.2.011 Site # 143

Orbassano, Italy

Location

S320.2.011 Site # 250

Bialystok, Poland

Location

S320.2.011 Site # 231

Inowrocław, Poland

Location

S320.2.011 Site # 236

Krakow, Poland

Location

S320.2.011 Site # 249

Lodz, Poland

Location

S320.2.011 Site # 243

Oława, Poland

Location

S320.2.011 Site # 240

Poznan, Poland

Location

S320.2.011 Site # 247

Przeworsk, Poland

Location

S320.2.011 Site # 242

Puławy, Poland

Location

S320.2.011 Site # 251

Płock, Poland

Location

S320.2.011 Site # 239

Radom, Poland

Location

S320.2.011 Site # 232

Ruda Śląska, Poland

Location

S320.2.011 Site # 245

Starogard Gdański, Poland

Location

S320.2.011 Site # 234

Torun, Poland

Location

S320.2.011 Site # 248

Torun, Poland

Location

S320.2.011 Site # 238

Tychy, Poland

Location

S320.2.011 Site # 233

Wroclaw, Poland

Location

S320.2.011 Site # 265

Baia Mare, Romania

Location

S320.2.011 Site # 262

Brăila, Romania

Location

S320.2.011 Site # 260

Bucharest, Romania

Location

S320.2.011 Site # 263

Bucharest, Romania

Location

S320.2.011 Site # 267

Bucharest, Romania

Location

S320.2.011 Site # 264

Suceava, Romania

Location

S320.2.011 Site # 261

Târgovişte, Romania

Location

S320.2.011 Site # 266

Timișoara, Romania

Location

S320.2.011 Site # 294

Kazan', Russia

Location

S320.2.011 Site # 306

Krasnodar, Russia

Location

S320.2.011 Site # 290

Moscow, Russia

Location

S320.2.011 Site # 297

Moscow, Russia

Location

S320.2.011 Site # 299

Moscow, Russia

Location

S320.2.011 Site # 301

Moscow, Russia

Location

S320.2.011 Site # 303

Moscow, Russia

Location

S320.2.011 Site # 304

Moscow, Russia

Location

S320.2.011 Site # 305

Moscow, Russia

Location

S320.2.011 Site # 291

Saint Petersburg, Russia

Location

S320.2.011 Site # 292

Saint Petersburg, Russia

Location

S320.2.011 Site # 298

Saint Petersburg, Russia

Location

S320.2.011 Site # 300

Saint Petersburg, Russia

Location

S320.2.011 Site # 302

Saint Petersburg, Russia

Location

S320.2.011 Site # 293

Voronezh, Russia

Location

S320.2.011 Site # 295

Yaroslavl, Russia

Location

S320.2.011 Site # 335

Dnipropetrovsk, Ukraine

Location

S320.2.011 Site # 332

Ivano-Frankivsk, Ukraine

Location

S320.2.011 Site # 334

Kharkiv, Ukraine

Location

S320.2.011 Site # 330

Kyiv, Ukraine

Location

S320.2.011 Site # 338

Kyiv, Ukraine

Location

S320.2.011 Site # 331

Luhansk, Ukraine

Location

S320.2.011 Site # 333

Lutsk, Ukraine

Location

S320.2.011 Site # 337

Odesa, Ukraine

Location

Related Publications (1)

• Pang PS, Mehra M, Maggioni AP, Filippatos G, Middlebrooks J, Turlapaty P, Kazei D, Gheorghiade M; RENO-DEFEND Investigators. Rationale, design, and results from RENO-DEFEND 1: a randomized, dose-finding study of the selective A1 adenosine antagonist SLV320 in patients hospitalized with acute heart failure. Am Heart J. 2011 Jun;161(6):1012-23.e3. doi: 10.1016/j.ahj.2011.03.004.

  PMID: 21641345 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

SLV320 compound

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Robyn Bethany

  Solvay Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: February 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 17, 2010

Record last verified: 2010-09

Locations

RU (16); UA (8); CA (1); PL (16); DE (7); CL (3); US (28); DK (6); FR (6); RO (8); IT (6)