A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-06

Study Completion Date

2025-03-27

Brief Summary

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Primary Objectives

* To assess the safety and tolerability of RGLS8429
* To assess the impact of RGLS8429 on ADPKD biomarkers

Secondary Objectives

* To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
* To characterize the pharmacokinetic (PK) properties of RGLS8429
* To assess the impact of RGLS8429 on renal function

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Detailed Description

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This is a randomized, double-blind, placebo-controlled multiple ascending dose and an open-label fixed-dose Phase 1b study consisting of two parts, Part A and Part B. In Part A, multiple ascending doses of RGLS8429 or placebo will be administered via subcutaneous injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429. In Part B, a fixed-dose of RGLS8429 will be administered via subcutaneous injection to subjects with ADPKD to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of RGLS8429.

Conditions

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Autosomal Dominant Polycystic Kidney Disease ADPKD Polycystic Kidney, Autosomal Dominant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The study will consist of two parts. Part A will consist of three sequential cohorts of approximately 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (approximately 36 subjects total). Part B will be an open-label fixed dose cohort of up to 30 subjects. .

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This study will have two parts. Part A is the double-blind, randomized, placebo-controlled study. Part B is the open-label fixed-dose study.

Study Groups

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RGLS8429

The randomized,double blind part of the study (Part A) will consist of three sequential cohorts of approximately 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total).

* Cohort 1: first dose level of RGLS8429 or placebo
* Cohort 2: second dose level of RGLS8429 or placebo
* Cohort 3: third dose level of RGLS8429 or placebo

Group Type EXPERIMENTAL