Kidney DiseasesPhase 4NCT00863707

A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

A Phase 4 study testing Regadenoson in people with Kidney Diseases and Coronary Artery Disease, run by Astellas Pharma Inc at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Diseases, Coronary Artery Disease
What is being tested?: Regadenoson
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 511 participants
Where: 41 sitesUnited States
Study dates: Apr 2009to Dec 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subject has a Stage III or Stage IV renal impairment based on the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) glomerular filtration rate (GFR) classification
Subject has a diagnosis of Coronary Artery Disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity (Body Mass Index (BMI) > 30)
Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson

Who cannot join

Subject has a history of an additional clinically significant illness, medical condition, or laboratory abnormality within 2 weeks prior to Screening
Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Study site
Anniston, Alabama, 36207
Study site
Auburn, Maine, 04210
Study site
Bell Gardens, California, 90202
Study site
Bend, Oregon, 97701
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60616
Study site
Detroit, Michigan, 48202
Study site
Duncansville, Pennsylvania, 16635
Study site
Ellijay, Georgia, 38540
Study site
Flint, Michigan, 48504
Study site
Fort Lauderdale, Florida, 33308
Study site
Fullerton, California, 92835
Study site
Garden Grove, California, 92845
Study site
Houston, Texas, 77055
Study site
Houston, Texas, 77074
Study site
Indiana, Pennsylvania, 15701
Study site
Knoxville, Tennessee, 37920
Study site
Little Rock, Arkansas, 72204
Study site
Los Angeles, California, 90017
Study site
Los Angeles, California, 90022
Study site
Miami, Florida, 33173
Study site
Minneapolis, Minnesota, 55415
Study site
Mission Viejo, California, 92691
Study site
New York, New York, 10010
Study site
Newark, Delaware, 19713
Study site
Oakland, California, 94609
Study site
Oklahoma City, Oklahoma, 73103
Study site
Orlando, Florida, 32809
Study site
Ridgewood, New Jersey, 07450
Study site
Roseville, California, 95661
Study site
Santa Ana, California, 92704
Study site
Somerset, New Jersey, 08873
Study site
Spartanburg, South Carolina, 29303
Study site
Springfield, Ohio, 45505
Study site
Springfield Gardens, New York, 11413
Study site
Sugar Grove, Texas, 77478
Study site
Trinity, Florida, 34655
Study site
Tyrone, Pennsylvania, 16686
Study site
Wilmington, Delaware, 19808
Study site
Winter Park, Florida, 32789
Study site
Wyomissing, Pennsylvania, 19610

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About this study

Official title: A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.

Conditions: Kidney Diseases, Coronary Artery Disease
Being tested: Regadenoson, Placebo
Keywords: regadenoson, chronic kidney disease stage III, chronic kidney disease stage IV, renal impairment, coronary artery disease
Medical subject headings: Kidney Diseases, Coronary Artery Disease, Renal Insufficiency, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RegadenosonDrug
Also called CVT-3146, Lexiscan
IV
PlaceboDrug
IV

Study groups in NCT00863707
Study group	Role	What they receive
Placebo	Placebo comparator	Matching intravenous (IV) bolus injection Receives: Drug: Placebo
Regadenoson	Experimental	0.4 mg/5 mL intravenous bolus injection Receives: Drug: Regadenoson

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)
The data represents the numbers of subjects reporting Serious TEAEs.
TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug.
Measured: 24 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Dec 2009

First posted18 Mar 2009 (estimated)
Study startApr 2009
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney DiseasesStudies 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 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 511 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00863707
Sponsor's protocol ID: 3606-CL-3010
Status last verified: May 2012
First submitted: 16 Mar 2009
Last updated: 18 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ananthasubramaniam K, Weiss R, McNutt B, Klauke B, Feaheny K, Bukofzer S. A randomized, double-blind, placebo-controlled study of the safety and tolerance of regadenoson in subjects with stage 3 or 4 chronic kidney disease. J Nucl Cardiol. 2012 Apr;19(2):319-29. doi: 10.1007/s12350-011-9508-3. Epub 2012 Jan 19.
PubMed 22259009

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
ClinicalTrials.gov ID: NCT00863707
Acronym / sponsor ID: 3606-CL-3010
Conditions: Kidney Diseases, Coronary Artery Disease
Keywords: regadenoson, chronic kidney disease stage III, chronic kidney disease stage IV, renal impairment, coronary artery disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 511 participants (actual)
Lead sponsor: Astellas Pharma IncIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 18 Mar 2009 (estimated)
Results: Posted 31 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboMatching intravenous (IV) bolus injection
Regadenoson	Experimental	Drug: Regadenoson0.4 mg/5 mL intravenous bolus injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject has a Stage III or Stage IV renal impairment based on the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) glomerular filtration rate (GFR) classification
Subject has a diagnosis of Coronary Artery Disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity (Body Mass Index (BMI) > 30)
Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson

Key exclusion criteria (2 listed)

Subject has a history of an additional clinically significant illness, medical condition, or laboratory abnormality within 2 weeks prior to Screening
Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete

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
RegadenosonAlso: CVT-3146, LexiscanIV	Drug	Regadenoson
PlaceboIV	Drug	Placebo

Primary outcome

Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)
Time frame: 24 hours post dose
The data represents the numbers of subjects reporting Serious TEAEs. TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug.

Results and safety

Results posted to the registry on 31 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	174	170
Regadenoson	337	334

Primary outcome: Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)

Time frame: 24 hours post dose. Number. Unit: Subjects

Measure	Placebo n = 170	Regadenoson n = 334
Value	0	0

Population analysed: The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug.

Adverse events

Time frame: Adverse Event collection began immediately following study drug administration through the follow-up visit. All Serious Adverse Events (SAEs) occurring until 30 days after dosing were reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 170 (0.6%)	20 of 170 (11.8%)	Not reported
Regadenoson	0 of 334 (0%)	184 of 334 (55.1%)	Not reported

Limitations and caveats (from the sponsor): Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22259009Ananthasubramaniam K, Weiss R, McNutt B, Klauke B, Feaheny K, Bukofzer S. A randomized, double-blind, placebo-controlled study of the safety and tolerance of regadenoson in subjects with stage 3 or 4 chronic kidney disease. J Nucl Cardiol. 2012 Apr;19(2):319-29. doi: 10.1007/s12350-011-9508-3. Epub 2012 Jan 19.
Link to Prescribing InformationLink provided by the sponsor.

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Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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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.

Central Contact study director

Astellas Pharma Global Development

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Regadenoson in people with Kidney Diseases and Coronary Artery Disease, run by Astellas Pharma Inc at 41 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 4 inclusion and 2 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 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) (time frame: 24 hours post dose). 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 NCT00863707, 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 18 May 2012.