A Phase 2b Diabetic Kidney Disease Study
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease
1 other identifier
interventional
609
7 countries
97
Brief Summary
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2019
Typical duration for phase_2
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2019
CompletedStudy Start
First participant enrolled
November 18, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2023
CompletedResults Posted
Study results publicly available
July 10, 2024
CompletedJuly 10, 2024
July 1, 2024
3.5 years
November 18, 2019
May 14, 2024
July 8, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline to Day 169 (Week 24) in UACR - Per Protocol Population
UACR values are collected as triplicates at baseline and at each CSP planned visit. For each triplicate, the UACR are averaged with geometric mean. Baseline is defined as the geometric mean of UACR measurements prior to first dose of study treatment. For the intercurrent events, if a subject is lost to follow-up (EOT), discontinues treatment due to AE, or uses prohibited medication, the UACR data are treated as missing on or after the event and no imputation is performed. The LS means of percent change and difference in percent change, corresponding 90% confidence intervals are calculated based on a mixed model with repeated measures (MMRM) of log (UACR post-baseline/UACR baseline) as the response, adjusting for fixed effects of treatment, visit, and treatment-by-visit interaction, SGLT2i, region (Japan or ROW), baseline log UACR, and baseline log UACR-by-visit interaction. The MMRM includes UACR values at protocol specified visits from baseline up to Day 169.
From baseline to Day 169
Secondary Outcomes (9)
Percent Change From Baseline to Day 85 (Week 12) in UACR - Per Protocol Population
From baseline to Day 85
Percent Change From Day 85 (Week 12) to Day 169 (Week 24) in UACR - Per Protocol Population
From Day 85 to Day 169
Proportion of Subjects With Reduction in UACR at Day 169 (Week 24) - Per Protocol Population
Baseline and Day 169
Percent Change From Baseline to Day 169 (Week 24) in UACR - Full Analysis Population
From baseline to Day 169
Percent Change From Baseline to Day 85 (Week 12) in UACR - Full Analysis Population
From baseline to Day 85
- +4 more secondary outcomes
Other Outcomes (1)
Plasma Concentration of MEDI3506 - PK Analysis Population
Day 1, Day 29, Day 85 and Day 169
Study Arms (5)
Group 1
EXPERIMENTALMEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).
Group 2
EXPERIMENTALMEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).
Group 3
EXPERIMENTALMEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).
Group 4
EXPERIMENTALMEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).
Group 5
PLACEBO COMPARATORPlacebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (97)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Huntsville, Alabama, 35805, United States
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Mesa, Arizona, 85210, United States
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Alhambra, California, 91801, United States
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Glendale, California, 91204, United States
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Granada Hills, California, 91344, United States
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Huntington Park, California, 90255, United States
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Northridge, California, 91324, United States
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Sacramento, California, 95821, United States
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San Diego, California, 92123, United States
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San Dimas, California, 91773, United States
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Vacaville, California, 95687, United States
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Fleming Island, Florida, 32003, United States
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Hialeah, Florida, 33016, United States
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Jacksonville, Florida, 32204, United States
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Miami, Florida, 33015, United States
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Atlanta, Georgia, 30338, United States
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Honolulu, Hawaii, 96814, United States
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Chicago, Illinois, 60607, United States
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Chicago, Illinois, 60643, United States
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Iowa City, Iowa, 52242, United States
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Manhattan, Kansas, 66502, United States
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Topeka, Kansas, 66606, United States
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Wichita, Kansas, 67214, United States
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Flint, Michigan, 48504, United States
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Henderson, Nevada, 89014, United States
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Las Vegas, Nevada, 89129, United States
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Berlin, New Jersey, 08009, United States
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Charlotte, North Carolina, 28204, United States
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Greensboro, North Carolina, 27408, United States
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Greenville, North Carolina, 27834, United States
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Morehead City, North Carolina, 28557, United States
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Maumee, Ohio, 43537, United States
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Oklahoma City, Oklahoma, 73116, United States
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Bethlehem, Pennsylvania, 18017, United States
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East Providence, Rhode Island, 02915, United States
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Columbia, South Carolina, 29203, United States
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Memphis, Tennessee, 38119, United States
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Cypress, Texas, 77429, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77079, United States
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Katy, Texas, 77450, United States
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San Antonio, Texas, 78212, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78251, United States
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St. George, Utah, 84790, United States
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Burke, Virginia, 22015, United States
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Tacoma, Washington, 98405, United States
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Morgantown, West Virginia, 26506, United States
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Buenos Aires, 1425DES, Argentina
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Buenos Aires, C1056ABJ, Argentina
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Buenos Aires, C1429BWN, Argentina
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CABA, C1120AAC, Argentina
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Caba, C1128AAF, Argentina
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CABA, C1425AGC, Argentina
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Corrientes, W3400AMZ, Argentina
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Córdoba, X5000AAW, Argentina
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Mar del Plata, 7600, Argentina
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Pergamino, B2700LDK, Argentina
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Ramos Mejía, B1704ETD, Argentina
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Rosario, S2000DNM, Argentina
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San Luis, D5700CTA, Argentina
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San Nicolás, B2900DMH, Argentina
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San Vicente, 5006, Argentina
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Calgary, Alberta, T2H 2G4, Canada
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Red Deer, Alberta, T4N 6V7, Canada
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Brampton, Ontario, L6S 0S9, Canada
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Brampton, Ontario, L6T 0G1, Canada
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Concord, Ontario, L4K 4M2, Canada
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Etobicoke, Ontario, M9R 4E1, Canada
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Toronto, Ontario, M4G 3E8, Canada
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Concepción, Chile
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Ñuñoa, 8520398, Chile
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Santiago, 7500021, Chile
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Santiago, 7500710, Chile
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Santiago, 8320000, Chile
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Santiago, Chile
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Victoria, Chile
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Chūōku, 103-0027, Japan
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Fukuoka, 815-8555, Japan
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Ise-shi, 516-8512, Japan
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Kisarazu-shi, 292-8535, Japan
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Koshigaya-shi, 343-8577, Japan
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Nagano, 388-8004, Japan
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Nagoya, 451-8511, Japan
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Nishinomiya-Shi, 662-0918, Japan
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Osaka, 530-0001, Japan
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Osaka, 558-8558, Japan
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Sayama-Shi, Japan
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Piura, Peru
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Gangnam-Gu, 6273, South Korea
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Goyang-si, 10444, South Korea
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Jongno-gu, 110-746, South Korea
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Seongbuk-Gu, 02841, South Korea
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Seoul, 06351, South Korea
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Suwon, 16499, South Korea
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Wŏnju, 26426, South Korea
Related Publications (2)
Hofherr A, Maki-Petaja K, Selvarajah V, Grice D, Bartesaghi S, Jimenez E, Pecoits-Filho R, Heerspink HJL. Inhibition of IL-33 in Diabetic Kidney Disease: A Randomized, Placebo-Controlled Phase 2b Trial. J Am Soc Nephrol. 2025 Dec 5. doi: 10.1681/ASN.0000000966. Online ahead of print. No abstract available.
PMID: 41563367DERIVEDHofherr A, Liarte Marin E, Musial B, Seth A, Slidel T, Conway J, Baker D, Hansen PBL, Challis B, Bartesaghi S, Bhat M, Pecoits-Filho R, Tu X, Selvarajah V, Woollard K, Heerspink HJL. Inhibition of Interleukin-33 to Reduce Glomerular Endothelial Inflammation in Diabetic Kidney Disease. Kidney Int Rep. 2024 Mar 18;9(6):1876-1891. doi: 10.1016/j.ekir.2024.03.009. eCollection 2024 Jun.
PMID: 38899206DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
41 randomized participants were excluded from analysis populations in order to avoid heterogeneity in the data (bias, etc.) : * 2 participants did not received any IP * 24 participants were enrolled in phase 2a without having the possibility to be enrolled in phase 2b * 15 participants were randomized in a site with GCP breach (inability to confirm the validity of the data reported) These 41 participants are excluded from Baseline characteristics (558 participants).
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This is a double-blinded study in which MEDI3506 and placebo. Neither the subject nor any of the investigator or sponsor staff who are involved in the treatment or clinical evaluation of the subjects will be aware of the treatment received.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2019
First Posted
November 20, 2019
Study Start
November 18, 2019
Primary Completion
May 16, 2023
Study Completion
May 16, 2023
Last Updated
July 10, 2024
Results First Posted
July 10, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared