Heart FailurePhase 1NCT01444872
Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
A Phase 1 study testing TRV120027 and Normal Saline in people with Heart Failure and Kidney Disease, run by Trevena Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Heart Failure, Kidney Disease
- What is being tested?
- TRV120027 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2011to Jun 2012
- Phase
- Phase 1
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent
- Heart Failure
- Mild to moderate renal dysfunction
- Age 18- <75
- Males and females (non-childbearing potential)
Who cannot join
- Any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the Investigator based on medical history, physical examination or laboratory tests
- Any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the Investigator
- Allergy or clinically-significant intolerance to ARBs or ACE inhibitors
- Clinical signs or symptoms of acute decompensated heart failure
- Pregnant or lactating
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Duke Clinical Research Unit
Durham, North Carolina, 27705
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
DaVita Clinical Research
Minneapolis, Minnesota, 55404
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled, Adaptive, Ascending Dose Study to Evaluate the Effects of TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Mild to Moderate Renal Dysfunction
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.
- Conditions
- Heart Failure, Kidney Disease
- Being tested
- TRV120027, Normal Saline
- Medical subject headings
- Heart Failure, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRV120027Drug
IV infusion
Normal SalineDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| TRV120027 | Experimental | TRV120027 administered as an IV infusion Receives: Drug: TRV120027 |
| Normal Saline | Placebo comparator | Normal Saline administered as an IV infusion Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Glomerular Filtration Rate
Assessments of glomerular filtration rate are made hourly during the 6-hour study drug infusion on study Day 1 and study Day 3. GFR in hours 4-6 are compared to GFR in hours 1-3, and comparisons made between Placebo and TRV120027.
Measured: Every hour during final 6 hours of study drug infusion
Change from Baseline in Vital Signs (Blood pressure, heart rate)
Vital signs measurements made during and following drug infusion will be evaluated as a change from baseline, and comparing placebo to TRV120027. Assessments are made on study Day 1 and study Day 3.
Measured: Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevena Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444872
- Sponsor's protocol ID
- CP120027.1002
- Status last verified
- Aug 2012
- First submitted
- 19 Sep 2011
- Last updated
- 27 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled, Adaptive, Ascending Dose Study to Evaluate the Effects of TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Mild to Moderate Renal Dysfunction
- ClinicalTrials.gov ID
- NCT01444872
- Acronym / sponsor ID
- CP120027.1002
- Conditions
- Heart Failure, Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Trevena Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Oct 2011 (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 evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal dysfunction.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRV120027 | Experimental | Drug: TRV120027TRV120027 administered as an IV infusion |
| Normal Saline | Placebo comparator | Drug: Normal SalineNormal Saline administered as an IV infusion |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written Informed Consent
- Heart Failure
- Mild to moderate renal dysfunction
- Age 18- <75
- Males and females (non-childbearing potential)
Key exclusion criteria (5 listed)
- Any significant disease or condition that would interfere with the interpretation of safety or efficacy or efficacy data as determined by the Investigator based on medical history, physical examination or laboratory tests
- Any other serious life threatening disease that may impair the interpretation of safety or efficacy data from the study as determined by the Investigator
- Allergy or clinically-significant intolerance to ARBs or ACE inhibitors
- Clinical signs or symptoms of acute decompensated heart failure
- Pregnant or lactating
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 |
|---|---|---|
| TRV120027IV infusion | Drug | TRV120027 |
| Normal SalineIV infusion | Drug | Normal Saline |
Primary outcome
Change from Baseline Glomerular Filtration Rate
Time frame: Every hour during final 6 hours of study drug infusion
Assessments of glomerular filtration rate are made hourly during the 6-hour study drug infusion on study Day 1 and study Day 3. GFR in hours 4-6 are compared to GFR in hours 1-3, and comparisons made between Placebo and TRV120027.
Change from Baseline in Vital Signs (Blood pressure, heart rate)
Time frame: Baseline, during infusion, and following infusion, on Study Day 1 and Study Day 3
Vital signs measurements made during and following drug infusion will be evaluated as a change from baseline, and comparing placebo to TRV120027. Assessments are made on study Day 1 and study Day 3.
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 27 Aug 2012.
- Sponsor's WebsiteLink provided by the sponsor.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRV120027 and Normal Saline in people with Heart Failure and Kidney Disease, run by Trevena Inc. at 4 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 5 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 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change from Baseline Glomerular Filtration Rate (time frame: Every hour during final 6 hours of study drug infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2012.