CLBS201 in Patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)
Phase 1
Completed
- Conditions
- Chronic Kidney Diseases
- Interventions
- Drug: CLBS201
- Registration Number
- NCT04990427
- Lead Sponsor
- Lisata Therapeutics, Inc.
- Brief Summary
CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- Adults aged 18 to 75 years, inclusive
- Documented diagnosis of type 2 diabetes
- eGFR of 30 to <45 mL/min/1.73m at the screening visit.
- UACR 300 mg/g to ≤ 5000 mg/g
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Exclusion Criteria
- Hemoglobin < 10 g/dL
- Hemoglobin A1c ≥8% at the time of screening
- Acute kidney injury within 6 months prior to screening
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CLBS201 CLBS201 CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation.
- Primary Outcome Measures
Name Time Method Serious Adverse Events 6 Months Proportion of patients with a treatment-emergent serious adverse event
- Secondary Outcome Measures
Name Time Method Estimated Glomerular Filtration Rate (eGFR) 6 Months Change in eGFR from baseline
UACR & UPCR 6 Months Change in UACR \& UPCR from baseline
Trial Locations
- Locations (1)
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States