Multiple Doses of DM199 in Patients With Chronic Kidney Disease
Last updated on July 2021Recruitment
- 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