Direct Renin Inhibition and the Kidney

NCT ID: NCT01217736

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-11-30

Brief 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.

Conditions

Renal Function

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

VTP-27999

Group Type: EXPERIMENTAL

VTP-27999

Intervention Type: DRUG

single dose, tablet

aliskiren

Group Type: ACTIVE_COMPARATOR

aliskiren

Intervention Type: DRUG

single dose, tablet

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

single dose, tablet

Interventions

aliskiren

single dose, tablet

Intervention Type: DRUG

placebo

single dose, tablet

Intervention Type: DRUG

VTP-27999

single dose, tablet

Intervention Type: DRUG

Other Intervention Names

Tekturna

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Vitae Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norman K Hollenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital, Boston, MA

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Barkoudah E, Danser AHJ, van Thiel BS, Fisher NDL, Gregg R, Hollenberg NK. Journal of the American Society of Hypertension 9(4)

Reference Type: RESULT

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.

Reference Type: RESULT

PMID: 26882043 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/26882043

maximum renal responses in healthy study participants: VTP-27999 versus aliskiren

Other Identifiers

2010P001281

Identifier Type: OTHER

Identifier Source: secondary_id

VTP-27999-005

Identifier Type: -

Identifier Source: org_study_id