NCT04123613

Multiple Doses of DM199 in Patients With Chronic Kidney Disease (REDUX)

A Multi-Center Open-label Investigation to Assess the Safety and Efficacy of Multiple Doses of DM199 in Patients With Chronic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: DiaMedica Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, Phase II, multi-center study evaluating multiple doses of DM199 in participants with chronic kidney disease.

Detailed description

This is an open-label, Phase II, multi-center study evaluating DM199 in approximately 90 Participants in three cohorts. Cohort I: African Americans with CKD (Stage II or III), hypertension and non-diabetic Cohort II: Participants with IgA nephropathy diagnosis and CKD (Stage II or III) Cohort III: Diabetes Mellitus (Type II) with CKD (Stage II or III) and hypertension Participants in each cohort will be enrolled in a parallel assignment to one of two doses: Dose 1: DM199 2.0 µg/kg SC 2x week for 95 days Dose 2: DM199 5.0 µg/kg SC 2x week for 95 days

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
DRUG	DM199	A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug

Timeline

• Start date: 2019-12-17
• Primary completion: 2022-03-16
• Completion: 2022-03-16
• First posted: 2019-10-11
• Last updated: 2022-03-31

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study