Renal FunctionPhase 1NCT01217736
Direct Renin Inhibition and the Kidney
A Phase 1 study testing aliskiren and VTP-27999 in people with Renal Function, run by Vitae Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The objective of the study is to determine the magnitude of the effect of direct renin inhibition by VTP-27999 on renal plasma flow and kidney function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Function
- What is being tested?
- aliskiren and VTP-27999
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Nov 2011
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male or female, 18-75 years of age
- Female subjects must be postmenopausal or surgically sterilized. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by plasma serum FSH level at screening between 23.0-116.3 mIU/ml. Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing.
- Male subjects, able to father a child, must be willing to use approved birth control methods for 2 weeks following completion of study.
Who cannot join
- Subjects under 18 and subjects over 75 years
- Diabetes Mellitus and/or kidney disease
- Myocardial infarction, stroke, or cardiovascular revascularization/angioplasty within the last 6 months
- Unstable angina pectoris or CAD requiring treatment with an excluded concomitant medication
- History of/or symptoms consistent with congestive heart failure
- Hypertension
Show all 27Show fewer
- History of left ventricular ejection fraction < 45%
- Current smokers or nicotine patch
- Pregnant or lactating females
- Cancer or any life threatening illness with expected death within 2 years or by completion of the study
- Serum creatinine >1.4 mg/dl
- Serum potassium <3.5 or >5.2 mmol/L without medication
- Serum albumin < 2.0 g/dL
- Hemoglobin < 11.5 g/dL or Hematocrit < 34%
- Any serum AST >/= 60 or ALT >/= 75 IU/L
- Use of any prescription drugs which may affect the renin-angiotensin-aldosterone system or with known effect on renal hemodynamics are not allowed within 10 days prior to dosing or during the study
- Use of CYP3A4 inhibitors (e.g. Diltiazem, Ketoconazole, Nifedipine, or Verapamil)
- Use of any prescription medication is prohibited within 14 days (or, if known, for at least 5 half-lives, if longer) prior to dosing, unless approved by both the Investigator and the Sponsor
- Use of any over-the-counter (OTC) medication, including herbal products, is prohibited within the 14 days prior to dosing, unless approved by both the Investigator and the Sponsor
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing
- A known hypersensitivity or contraindication to the study drugs (Aliskiren) or drugs similar to the study drugs or PAH, and inulin
- Any surgical or medical condition which alters absorption, distribution, metabolism or excretion of drugs or which may jeopardize the patient subject during this study, including gastric bypass
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by past medical history
- Acute infections and/or significant illness within 3 weeks of planned enrollment into this study
- Any medical condition in the investigator's opinion, which renders the subject unable to complete the study or which would produce significant risk to the subject
- Administration of any other investigational drug within 30 days of planned dosing in the study
- Poor intravenous (IV) access as determined by the study staff
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The objective of the study is to determine the magnitude of the effect of direct renin inhibition by VTP-27999 on renal plasma flow and kidney function.
- Conditions
- Renal Function
- Being tested
- aliskiren, placebo, VTP-27999
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aliskirenDrug
Also called Tekturna
single dose, tablet
placeboDrug
single dose, tablet
VTP-27999Drug
single dose, tablet
| Study group | Role | What they receive |
|---|---|---|
| VTP-27999 | Experimental | Not described Receives: Drug: VTP-27999 |
| aliskiren | Active comparator | Not described Receives: Drug: aliskiren |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal plasma flow
as measured by PAH clearance
Measured: pre-dose to 6 hours post-dose
Secondary outcomes (3)
glomerular filtration rate
Measured: pre-dose to 6 hours post-dose
RAAS pathway biomarkers
renin, prorenin, plasma renin activity, ang II
Measured: pre-dose to 24 hours post-dose
VTP-27999 concentrations
Measured: pre-dose to 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.
- First posted8 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal FunctionStudies 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitae Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Norman K Hollenberg, MD, PhD, Principal investigator, Brigham and Women's Hospital, Boston, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217736
- Sponsor's protocol ID
- VTP-27999-005
- Other IDs
- 2010P001281
- Status last verified
- Feb 2016
- First submitted
- 6 Oct 2010
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barkoudah E, Danser AHJ, van Thiel BS, Fisher NDL, Gregg R, Hollenberg NK. Journal of the American Society of Hypertension 9(4)
Barkoudah E, van Thiel BS, Fisher ND, Gregg RA, Danser AH, Moukarbel GV, Hollenberg NK. Maximum renal responses to renin inhibition in healthy study participants: VTP-27999 versus aliskiren. J Hypertens. 2016 May;34(5):935-41. doi: 10.1097/HJH.0000000000000860.
PubMed 26882043
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Renin Inhibition and the Kidney
- ClinicalTrials.gov ID
- NCT01217736
- Acronym / sponsor ID
- VTP-27999-005
- Conditions
- Renal Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vitae Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Oct 2010 (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 objective of the study is to determine the magnitude of the effect of direct renin inhibition by VTP-27999 on renal plasma flow and kidney function.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VTP-27999 | Experimental | Drug: VTP-27999 |
| aliskiren | Active comparator | Drug: aliskiren |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult male or female, 18-75 years of age
- Female subjects must be postmenopausal or surgically sterilized. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Menopause will be confirmed by plasma serum FSH level at screening between 23.0-116.3 mIU/ml. Female subjects who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing.
- Male subjects, able to father a child, must be willing to use approved birth control methods for 2 weeks following completion of study.
Key exclusion criteria (27 listed)
- Subjects under 18 and subjects over 75 years
- Diabetes Mellitus and/or kidney disease
- Myocardial infarction, stroke, or cardiovascular revascularization/angioplasty within the last 6 months
- Unstable angina pectoris or CAD requiring treatment with an excluded concomitant medication
- History of/or symptoms consistent with congestive heart failure
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 |
|---|---|---|
| aliskirenAlso: Tekturnasingle dose, tablet | Drug | aliskiren |
| placebosingle dose, tablet | Drug | placebo |
| VTP-27999single dose, tablet | Drug | VTP-27999 |
Primary outcome
renal plasma flow
Time frame: pre-dose to 6 hours post-dose
as measured by PAH clearance
3 secondary outcomes
glomerular filtration rate
Time frame: pre-dose to 6 hours post-dose
RAAS pathway biomarkers
Time frame: pre-dose to 24 hours post-dose
VTP-27999 concentrations
Time frame: pre-dose to 24 hours post-dose
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 Feb 2016.
- Results publicationBarkoudah E, Danser AHJ, van Thiel BS, Fisher NDL, Gregg R, Hollenberg NK. Journal of the American Society of Hypertension 9(4)
- Results publication: PubMed 26882043Barkoudah E, van Thiel BS, Fisher ND, Gregg RA, Danser AH, Moukarbel GV, Hollenberg NK. Maximum renal responses to renin inhibition in healthy study participants: VTP-27999 versus aliskiren. J Hypertens. 2016 May;34(5):935-41. doi: 10.1097/HJH.0000000000000860.
- maximum renal responses in healthy study participants: VTP-27999 versus aliskirenLink 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.
Norman K Hollenberg, MD, PhD principal investigator
Brigham and Women's Hospital, Boston, MA
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 aliskiren and VTP-27999 in people with Renal Function, run by Vitae Pharmaceuticals, Inc. 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 3 inclusion and 27 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 Feb 2016. 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. 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?
renal plasma flow (time frame: pre-dose to 6 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 NCT01217736, which also lists 2 linked publications.
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 Feb 2016.