Direct Renin Inhibition and the Kidney

NCT01217736 | Completed Phase 1 DMC

• 2 other identifiers: VTP-27999-0052010P001281
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• renal plasma flow

  as measured by PAH clearance

  pre-dose to 6 hours post-dose

Secondary Outcomes (3)

• glomerular filtration rate

  pre-dose to 6 hours post-dose

• RAAS pathway biomarkers

  pre-dose to 24 hours post-dose

• VTP-27999 concentrations

  pre-dose to 24 hours post-dose

Study Arms (3)

VTP-27999

EXPERIMENTAL

Drug: VTP-27999

aliskiren

ACTIVE COMPARATOR

Drug: aliskiren

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

aliskiren DRUG

single dose, tablet

Also known as: Tekturna

aliskiren

placebo DRUG

single dose, tablet

placebo

VTP-27999 DRUG

single dose, tablet

VTP-27999

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vitae Pharmaceuticals, Inc.: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

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

  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.

  PMID: 26882043 RESULT

Related Links

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

MeSH Terms

Interventions

aliskiren; methyl (2-((3-chlorophenyl)(1-((2-(methylamino)-3-(tetrahydro-2H-pyran-3-yl)propyl)carbamoyl)piperidin-3-yl)methoxy)ethyl)carbamate

Study Officials

• Norman K Hollenberg, MD, PhD

  Brigham and Women's Hospital, Boston, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 8, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

US (1)