Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
60

Summary

Conditions
Kidney Diseases
Type
Interventional
Phase
Phase 2
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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: D...

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

Tracking Information

NCT #
NCT04123613
Collaborators
Not Provided
Investigators
Not Provided