- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01519037
Interaction Between a Calcimimetic Agent and the Renin Angiotensine Aldosterone System
March 3, 2020 updated by: Michel Burnier, Centre Hospitalier Universitaire Vaudois
Evaluation of the Interaction Between a Calcimimetic Agent (Cinacalcet) and the Renin Angiotensine Aldosterone System in Healthy Volunteers
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The clinical trial will be monocentric (Service of Nephrology and Hypertension at CHUV, Lausanne) and will include 24 patients.
The volunteers will get involved after inclusion (Inclusion Visit) in a crossover study over two double-blind periods.
The order of the two periods (placebo or cinacalcet) will be randomized.
Each period comprises 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.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1011
- CHUV, service de néphrologie/hypertension
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
• Female
- Age < 18 or > 45 years old
- Electrolyte disturbances, defined as any sodium, potassium, total or ionized calcium, phosphate or magnesium value outside of the laboratory's reference values (at the Inclusion Visit).
- Seropositive for HIV, HBV or HCV (at the Inclusion Visit).
- Positive detection of drugs in urine (opiates, cannabinoids, cocaine, benzodiazepines, amphetamines or barbiturates) (at the Inclusion Visit).
- Fall in SBP > or DBP > 10 mmHg after standing for 1 minute or any clinical manifestation of postural hypotension (at the Inclusion Visit).
- 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.
- Ongoing involvement or in the 60 days prior to the Inclusion Visit in another research study.
- Chronic use of any medication (prescribed or not) during the 4 weeks prior to the Inclusion Visit (only the use of medications such as paracetamol for headaches will be tolerated at the lowest dose possible.
- Use of any medication known as CYP P450 3A4 inhibitors during the 12 weeks prior to the Inclusion Visit (amiodarone, diltiazem, verapamil, ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, miconazol, ritonavir, nelfinavir, amprenavir, indinavir, atazanavir, erythromycin, clarithromycin, josamycin, telithromycin)
- Donation of blood, plasma and/or marrow in the 3 months prior to the Inclusion Visit
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: calcimimetic agent (cinacalcet)
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
|
one dose of oral cinacalcet, 60mg
|
Placebo Comparator: Placebo
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
|
one tablet of placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of cinacalcet compared to placebo on plasma renin activity
Time Frame: up to 36 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect of cinacalcet administered as single dose (compared to placebo) on plasma aldosterone and on hemodynamics
Time Frame: up to 36 days
|
to determine the effect of cinacalcet administered as single dose (compared to placebo) on plasma aldosterone and on hemodynamics (blood pressure, heart rate), under RAAS stimulating conditions (low sodium diet, furosemide injection).
|
up to 36 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michel Burnier, Professor, CHUV
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
January 24, 2012
First Submitted That Met QC Criteria
January 24, 2012
First Posted (Estimate)
January 26, 2012
Study Record Updates
Last Update Posted (Actual)
March 5, 2020
Last Update Submitted That Met QC Criteria
March 3, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011DR4219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Publication
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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