A phase 2b Diabetic Kidney Disease study
Study identifier:D9183C00001
ClinicalTrials.gov identifier:NCT04170543
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
Medical condition
Diabetic Kidney Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
MEDI3506, Placebo, Dapagliflozin
Sex
All
Actual Enrollment
609
Study type
Interventional
Age
18 Years - 101 Years
Date
Study Start Date: 18 Nov 2019
Primary Completion Date: 16 May 2023
Study Completion Date: 16 May 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168). | Drug: MEDI3506 Dose 1, Dose 2, Dose 3, Dose 4 Other Name: NA Drug: Dapagliflozin Dapagliflozin 10 mg Other Name: NA |
| Experimental: Group 2 MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168). | Drug: MEDI3506 Dose 1, Dose 2, Dose 3, Dose 4 Other Name: NA Drug: Dapagliflozin Dapagliflozin 10 mg Other Name: NA |
| Experimental: Group 3 MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168). | Drug: MEDI3506 Dose 1, Dose 2, Dose 3, Dose 4 Other Name: NA Drug: Dapagliflozin Dapagliflozin 10 mg Other Name: NA |
| Experimental: Group 4 MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168). | Drug: MEDI3506 Dose 1, Dose 2, Dose 3, Dose 4 Other Name: NA Drug: Dapagliflozin Dapagliflozin 10 mg Other Name: NA |
| Placebo Comparator: Group 5 Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168). | Drug: Placebo Placebo Other Name: NA Drug: Dapagliflozin Dapagliflozin 10 mg Other Name: NA |
