Phase 2
N=599
A Phase 2b Diabetic Kidney Disease Study
Diabetic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT04170543 ↗Enrolled (actual)
599
Serious AEs
10.2%
Results posted
Jul 2024
Primary outcome: Primary: Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population — -14.82; -17.25; -31.45; -29.70 Percentage change from baseline — p=0.8338
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MEDI3506 (Drug); Placebo (Drug); Dapagliflozin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population |
-14.82; -17.25; -31.45; -29.70; -20.96 | 0.8338 |
| SECONDARY Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population |
21.60; 5.77; -9.66; -0.53; 2.69 | 0.1929 |
| SECONDARY Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population |
-23.26; -17.69; -20.87; -25.87; -19.21 | 0.5474 |
| SECONDARY Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population |
43; 34; 28; 38; 59; 33 | — |
| SECONDARY Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population |
-15.82; -13.77; -28.98; -30.94; -21.19 | 0.8537 |
| SECONDARY Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population |
16.86; 7.59; -7.23; -5.03; 1.35 | 0.4226 |
| SECONDARY Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Full Analysis Population |
49; 36; 28; 41; 62; 37 | — |
| SECONDARY Immunogenicity of MEDI3506 - PK Analysis Population |
1; 6; 10; 12; 12; 0 | — |
| SECONDARY Asymptomatic Participants Tested Positive for COVID-19 During the Study - Safety Analysis Population |
79; 54; 50; 53; 70 | — |
| SECONDARY Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events Among COVID-19 Positive Participants - Safety Analysis Population |
47; 35; 23; 30; 40; 11 | — |
Summary
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
Eligibility Criteria
Key Inclusion Criteria
- Adult men or women ≥ 18 years of age.
- Diabetic kidney disease DKD defined as:
- diagnosis of T2DM
- eGFR 25-75 mL/min/1.73 m2
- UACR 100-3000 mg albumin/g creatinine
- BP ≤ 150/100 mmHg
- Stable dose of ACEi or ARB Key Exclusion Criteria
- Serum potassium > 5.5 mmol/L 2. Significant hepatic disease 3. Hemoglobin A1c > 10.5 % 4. B-type natriuretic peptide level > 200 pg/mL 5. History of clinically significant heart disease 6. Anticipated dialysis or renal transplantation within 1 year 7. History of underlying condition that predisposes the subject to infections 8. Significant infection (viral, bacterial, or fungal) 9. Amputation due to peripheral artery disease 10. Subjects with a positive diagnostic nucleic acid test for SARS-CoV-2 11. Pregnancy, breastfeeding or intention to become pregnant during the course of the study, 12. Any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ECG) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject's ability to participate in the study, or interfere with evaluation of the investigational product
Data sourced from ClinicalTrials.gov (NCT04170543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.