Kidney DiseasesPhase 1NCT00887627
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
A Phase 1 study testing conivaptan hydrochloride in people with Kidney Diseases and Hyponatremia, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial summary
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases, Hyponatremia
- What is being tested?
- conivaptan hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weighs at least 45 kg
- Body mass index between 18 and 40 kg/m2 inclusive
- Must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects
- Must have a screening and pre-dose estimated glomerular filtration rate (GFR) that corresponds with the level of renal impairment based on the abbreviated Modification of Diet in Renal Disease (MDRD) formula
- Female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal
Who cannot join
- Subject is known to be HIV positive or has HIV antibodies
- Has clinically significant history or presence of illness, medical condition, or laboratory abnormality
- Is Hepatitis positive
- Subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study
- History of substance abuse within 6 months prior to screening
- Has clinically significant history or presence of psychiatric illness, malignancy, or immunodeficiency syndrome
- Has abnormal liver function tests (ALT, AST, and/or bilirubin)
- Has had a blood transfusion or donated/lost more than 450ml of blood within 56 days of study drug administration or has donated plasma within 7 days prior to study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.
- Conditions
- Kidney Diseases, Hyponatremia
- Being tested
- conivaptan hydrochloride
- Keywords
- Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Kidney Diseases
- Medical subject headings
- Kidney Diseases, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conivaptan hydrochlorideDrug
Also called Vaprisol, YM087
intravenous
| Study group | Role | What they receive |
|---|---|---|
| 1. Mild Renal Function Impaired Subjects | Experimental | Not described Receives: Drug: conivaptan hydrochloride |
| 2. Moderate Renal Function Impaired Subjects | Experimental | Not described Receives: Drug: conivaptan hydrochloride |
| 3. Subjects with Normal Renal Function | Experimental | Not described Receives: Drug: conivaptan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure PK and protein binding of conivaptan
Measured: 5 days
Secondary outcomes (1)
Measure safety and tolerability of conivaptan
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Art Wheeler, MD, Study director, Cumberland Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887627
- Sponsor's protocol ID
- 087-CL-094
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2009
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Assess the Effects of Renal Impairment on the Pharmacokinetics of Intravenous Conivaptan
- ClinicalTrials.gov ID
- NCT00887627
- Acronym / sponsor ID
- 087-CL-094
- Conditions
- Kidney Diseases, Hyponatremia
- Keywords
- Pharmacokinetics, Protein Binding, Conivaptan, Vaprisol, Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 24 Apr 2009 (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.
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Mild Renal Function Impaired Subjects | Experimental | Drug: conivaptan hydrochloride |
| 2. Moderate Renal Function Impaired Subjects | Experimental | Drug: conivaptan hydrochloride |
| 3. Subjects with Normal Renal Function | Experimental | Drug: conivaptan hydrochloride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Weighs at least 45 kg
- Body mass index between 18 and 40 kg/m2 inclusive
- Must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects
- Must have a screening and pre-dose estimated glomerular filtration rate (GFR) that corresponds with the level of renal impairment based on the abbreviated Modification of Diet in Renal Disease (MDRD) formula
- Female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal
Key exclusion criteria (8 listed)
- Subject is known to be HIV positive or has HIV antibodies
- Has clinically significant history or presence of illness, medical condition, or laboratory abnormality
- Is Hepatitis positive
- Subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study
- History of substance abuse within 6 months prior to screening
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 |
|---|---|---|
| conivaptan hydrochlorideAlso: Vaprisol, YM087intravenous | Drug | 1. Mild Renal Function Impaired Subjects, 2. Moderate Renal Function Impaired Subjects, 3. Subjects with Normal Renal Function |
Primary outcome
Measure PK and protein binding of conivaptan
Time frame: 5 days
1 secondary outcome
Measure safety and tolerability of conivaptan
Time frame: 5 days
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 2 May 2014.
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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.
Art Wheeler, MD study director
Cumberland Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing conivaptan hydrochloride in people with Kidney Diseases and Hyponatremia, run by Cumberland Pharmaceuticals at 1 site 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 8 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 2 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Measure PK and protein binding of conivaptan (time frame: 5 days). 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 2 May 2014.