Heart Failure, CongestivePhase 2NCT00159614
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
A Phase 2 study testing KW-3902IV in people with Heart Failure, Congestive and Renal Insufficiency, run by NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 6 sites in United States.
Trial summary
The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Renal Insufficiency
- What is being tested?
- KW-3902IV
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable congestive heart failure
- Impaired renal function
- Taking oral loop diuretic
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Ayer, Massachusetts
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Kalamazoo, Michigan
Study site
San Diego, California
Study site
Tullahoma, Tennessee
About this study
Official title: Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment
The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.
- Conditions
- Heart Failure, Congestive, Renal Insufficiency
- Being tested
- KW-3902IV
- Keywords
- renal insufficiency, diuretic, heart failure, congestive
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KW-3902IVDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of KW-3902IV alone or with loop diuretic on renal function.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159614
- Sponsor's protocol ID
- CKI-203
- Status last verified
- Jan 2008
- First submitted
- 7 Sep 2005
- Last updated
- 29 Jan 2008
- Results posted
- No
Publications
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.
PubMed 17923351
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With Congestive Heart Failure (CHF) and Renal Impairment
- ClinicalTrials.gov ID
- NCT00159614
- Acronym / sponsor ID
- CKI-203
- Conditions
- Heart Failure, Congestive, Renal Insufficiency
- Keywords
- renal insufficiency, diuretic, heart failure, congestive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the safety and tolerability of KW-3902IV and measure its effect on renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable congestive heart failure
- Impaired renal function
- Taking oral loop diuretic
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KW-3902IV | Drug | – |
Primary outcome
Comparison of KW-3902IV alone or with loop diuretic on renal function.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2008.
- Derived from this study: PubMed 17923351Dittrich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KW-3902IV in people with Heart Failure, Congestive and Renal Insufficiency, run by NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of KW-3902IV alone or with loop diuretic on renal function.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2008.