NCT00159614

Brief Summary

The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

January 29, 2008

Status Verified

January 1, 2008

First QC Date

September 7, 2005

Last Update Submit

January 28, 2008

Conditions

Heart Failure, CongestiveRenal Insufficiency

Keywords

renal insufficiencydiureticheart failure, congestive

Outcome Measures

Primary Outcomes (1)

  • Comparison of KW-3902IV alone or with loop diuretic on renal function.

Interventions

KW-3902IVDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable congestive heart failure
  • Impaired renal function
  • Taking oral loop diuretic

You may not qualify if:

  • Acutely decompensated (unstable) and end stage heart failure
  • Diuretics other than loop diuretics
  • Pregnant or nursing
  • Inability to follow instructions
  • Participation in another clinical trial within past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Ayer, Massachusetts, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Kalamazoo, Michigan, United States

Location

Unknown Facility

Tullahoma, Tennessee, United States

Location

Related Publications (1)

  • Dittrich HC, Gupta DK, Hack TC, Dowling T, Callahan J, Thomson S. The effect of KW-3902, an adenosine A1 receptor antagonist, on renal function and renal plasma flow in ambulatory patients with heart failure and renal impairment. J Card Fail. 2007 Oct;13(8):609-17. doi: 10.1016/j.cardfail.2007.08.006.

    PMID: 17923351DERIVED

MeSH Terms

Conditions

Heart FailureRenal Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

September 1, 2005

Last Updated

January 29, 2008

Record last verified: 2008-01

Locations

US(6)