Interaction Between a Calcimimetic Agent and the Renin Angiotensine Aldosterone System

NCT01519037 | Completed DMC

• 1 other identifier: 2011DR4219
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate, in healthy volunteers, the acute modulating effect of cinacalcet on the RAAS, the effect of furosemide on parathyroid secretion of PTH and the interaction between furosemide and cinacalcet on parathyroid hormone secretion.

Conditions

Relationship Between Calcimimetic and the RAAS

Keywords

calcimimetic agent; RAAS; renin; aldosterone

Outcome Measures

Primary Outcomes (1)

• Effect of cinacalcet compared to placebo on plasma renin activity

  to determine the acute effect of a single high dose of cinacalcet compared to placebo on plasma renin activity (PRA), under RAAS-stimulating conditions (low sodium diet, furosemide injection) by PRA plasma measure

  up to 36 days

Secondary Outcomes (1)

• effect of cinacalcet administered as single dose (compared to placebo) on plasma aldosterone and on hemodynamics

  up to 36 days

Study Arms (2)

calcimimetic agent (cinacalcet)

ACTIVE COMPARATOR

3 days of a low-sodium diet (50 mmol of Na+ per day, equivalent to 3 grams of salt/day), followed by an investigation day at the hospital during which the subjects will be studied before and after exposure to the cinacalcet or the placebo. The 2 periods will be separated by a therapeutic wash-out lasting 14-28 days. The total length of the study per participant will be 1, max. 2 months

Drug: Cinacalcet 60 MG

Placebo

PLACEBO COMPARATOR

3 days of a low-sodium diet (50 mmol of Na+ per day, equivalent to 3 grams of salt/day), followed by an investigation day at the hospital during which the subjects will be studied before and after exposure to the cinacalcet or placebo. The 2 periods will be separated by a therapeutic wash-out lasting 14-28 days. The total length of the study per participant will be 1, max. 2 months

Drug: Placebo oral tablet

Interventions

Cinacalcet 60 MG DRUG

one dose of oral cinacalcet, 60mg

calcimimetic agent (cinacalcet)

Placebo oral tablet DRUG

one tablet of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subject
• Male
• Age \> 18 and \< 45 years old
• Caucasian
• Non-smoker
• BMI \>18 and \< 25 Kg/m2
• Normal clinical examination
• ECG normal, 12 leads
• Systolic arterial pressure (SBP) ≥100 ≤ 139 mmHg and diastolic arterial pressure (DBP) ≥50 ≤ 89 mmHg (after 5 minutes lying down, 3 measurements at 2-minute intervals; Omron machine; left arm)
• Heart rate (HR) ≥ 45 ≤ 90 beats/min
• Subject capable of understanding the written information and the written consent form.
• Subject must have given written, dated and signed consent before starting any trial procedure.

You may not qualify if:

• Female
• Age \< 18 or \> 45 years old
• Any history of diseases or clinically significant conditions which may be gastrointestinal (such as gastritis or gastric ulcer), respiratory, psychiatric, neurological (medical history of convulsions), renal, hepatic or cardiac or other diseases/conditions or abnormal physical signs which may interfere with the study's objectives. The investigator may disqualify any subject for a valid medical or psychiatric reason.
• Medical history of dependence on drugs or alcohol abuse as defined by the DSM IVR, criteria for diagnosing drug and alcohol abuse and dependence on drugs.
• Medical history of intolerant reactions to cinacalcet or furosemide (or derivatives of sulfamides)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

CHUV, service de néphrologie/hypertension

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

• Maillard MP, Tedjani A, Perregaux C, Burnier M. Calcium-sensing receptors modulate renin release in vivo and in vitro in the rat. J Hypertens. 2009 Oct;27(10):1980-7. doi: 10.1097/HJH.0b013e32832f0d22.

  PMID: 19593209 BACKGROUND

• Muller ME, Forni Ogna V, Maillard M, Stoudmann C, Zweiacker C, Anex C, Wuerzner G, Burnier M, Bonny O. Furosemide stimulation of parathormone in humans: role of the calcium-sensing receptor and the renin-angiotensin system. Pflugers Arch. 2015 Dec;467(12):2413-21. doi: 10.1007/s00424-015-1714-4. Epub 2015 Jun 20.

  PMID: 26089029 RESULT

MeSH Terms

Interventions

Cinacalcet

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Michel Burnier, Professor

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 26, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2014
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)