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MLS-101-206

A PHASE 2 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LORUNDROSTAT ALONE, AND LORUNDOSTAT IN COMBINATION WITH DAPAGLIFLOZIN, IN ADULTS WITH HYPERTENSION AND CHRONIC KIDNEY DISEASE WITH ALBUMINURIA

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Chronic kidney disease
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All genders
person-wave 18-100
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Overview

Principal Investigator: Lesley Inker

This is a phase 2 study that evaluates Lorundrostat in adults with Hypertension, Chronic Kidney Disease, and Albuminuria.

Study details

Inclusion Criteria
  • UARC within 300-3500 mg/g in First morning void.
  • At Screening, AOBP SBP of 135-180 mmHg, inclusive
  • On a stable treatment with an ACEi or ARB for at least 2 months prior to Screening
Exclusion Criteria
  • Subjects with known hypersensitivity to lorundrostat or any of its respective excipients
  • Treatment, or anticipated treatment, with triamterene and amiloride
  • Serum potassium >5.0 mmol/L at the Screening Visit and >4.8 mmol/L at Week 0 visit (prior to first dosing of study drug)
Study Requirements

10 visits in part A of assessments over the course of 26 weeks and 7 visits in part B of assessments of the course of 14 weeks. Blood draws would regularly occure.

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