Overview
A Phase 1/2 Study Evaluating the Safety and Efficacy of CLBS201 in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2024-08-15
2024-08-15
Target enrollment:
0
0
Participant gender:
All
All
Summary
CLBS201 will be studied to evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and Type 2 DM.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Caladrius Biosciences, Inc.
Criteria
Inclusion Criteria:1. Adults aged 18 to 75 years
2. Documented diagnosis of type 2 diabetes
3. eGFR of 30 to <45 mL/min/1.73m at the screening visit.
4. UACR 300 mg/g to ≤ 5000 mg/g
Exclusion Criteria:
1. Hemoglobin < 10 g/dL
2. Hemoglobin A1c ≥8% at the time of screening
3. Acute kidney injury within 6 months prior to screening