NCT01519037

Interaction Between a Calcimimetic Agent and the Renin Angiotensine Aldosterone System

Evaluation of the Interaction Between a Calcimimetic Agent (Cinacalcet) and the Renin Angiotensine Aldosterone System in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Relationship Between Calcimimetic and the RAAS

Interventions

Type	Name	Description
DRUG	Cinacalcet 60 MG	one dose of oral cinacalcet, 60mg
DRUG	Placebo oral tablet	one tablet of placebo

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-06-01
• Completion: 2014-06-01
• First posted: 2012-01-26
• Last updated: 2020-03-05

Locations

1 site across 1 country: Switzerland