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A Phase 2b Diabetic Kidney Disease Study

NCT ID: NCT04170543

Last Updated: 2024-07-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

609 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2023-05-16

Brief Summary

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A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

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Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes

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Detailed Description

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This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 on top of standard of care, including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) of 25-75 mL/min/1.73 m2 with a UACR in the range of 100-3000 mg/g, who meet all eligibility criteria. Approximately 565 subjects, among multiple countries will be randomized to MEDI3506 dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. All subjects will receive Dapagliflozin daily, as administered orally from Day 85 to Day 168. The primary objective is to evaluate the effect of MEDI3506 on albuminuria in subjects with DKD. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.

Conditions

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Diabetic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible subjects will be randomized to receive MEDI3506 or placebo as follows:

Group 1: MEDI3506 Dose 1. Group 2: MEDI3506 Dose 2. Group 3: MEDI3506 Dose 3 Group 4: MEDI3506 Dose 4 Group 5: Placebo (volume matched) All subjects will receive Dapa from Day 85 to Day 168.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Group 1

MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).

Group Type EXPERIMENTAL

MEDI3506

Intervention Type DRUG

Dose 1, Dose 2, Dose 3, Dose 4

Dapagliflozin

Intervention Type DRUG

Dapagliflozin 10 mg

Group 2

MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).

Group Type EXPERIMENTAL

MEDI3506

Intervention Type DRUG

Dose 1, Dose 2, Dose 3, Dose 4

Dapagliflozin

Intervention Type DRUG

Dapagliflozin 10 mg

Group 3

MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).

Group Type EXPERIMENTAL

MEDI3506

Intervention Type DRUG

Dose 1, Dose 2, Dose 3, Dose 4

Dapagliflozin

Intervention Type DRUG

Dapagliflozin 10 mg

Group 4

MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).

Group Type EXPERIMENTAL

MEDI3506

Intervention Type DRUG

Dose 1, Dose 2, Dose 3, Dose 4

Dapagliflozin

Intervention Type DRUG

Dapagliflozin 10 mg

Group 5

Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Dapagliflozin

Intervention Type DRUG

Dapagliflozin 10 mg

Interventions

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MEDI3506

Dose 1, Dose 2, Dose 3, Dose 4

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Dapagliflozin

Dapagliflozin 10 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adult men or women ≥ 18 years of age.
2. Diabetic kidney disease DKD defined as:

1. diagnosis of T2DM
2. eGFR 25-75 mL/min/1.73 m2
3. UACR 100-3000 mg albumin/g creatinine
3. BP ≤ 150/100 mmHg

Exclusion Criteria

1\. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

101 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mesa, Arizona, United States

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Alhambra, California, United States

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Glendale, California, United States

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Granada Hills, California, United States

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Huntington Park, California, United States

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Northridge, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Dimas, California, United States

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Vacaville, California, United States

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Fleming Island, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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Manhattan, Kansas, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Flint, Michigan, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Greenville, North Carolina, United States

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Morehead City, North Carolina, United States

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Maumee, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bethlehem, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Columbia, South Carolina, United States

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Memphis, Tennessee, United States

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Cypress, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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St. George, Utah, United States

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Burke, Virginia, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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CABA, , Argentina

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Caba, , Argentina

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CABA, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Mar del Plata, , Argentina

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Pergamino, , Argentina

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Ramos Mejía, , Argentina

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Rosario, , Argentina

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San Luis, , Argentina

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San Nicolás, , Argentina

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San Vicente, , Argentina

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Calgary, Alberta, Canada

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Red Deer, Alberta, Canada

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Brampton, Ontario, Canada

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Brampton, Ontario, Canada

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Concord, Ontario, Canada

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Etobicoke, Ontario, Canada

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Toronto, Ontario, Canada

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Concepción, , Chile

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Ñuñoa, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Victoria, , Chile

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Chūōku, , Japan

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Fukuoka, , Japan

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Ise-shi, , Japan

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Kisarazu-shi, , Japan

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Koshigaya-shi, , Japan

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Nagano, , Japan

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Nagoya, , Japan

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Nishinomiya-Shi, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Sayama-Shi, , Japan

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Piura, , Peru

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Gangnam-Gu, , South Korea

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Goyang-si, , South Korea

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Jongno-gu, , South Korea

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Seongbuk-Gu, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Wŏnju, , South Korea

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Countries

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United States Argentina Canada Chile Japan Peru South Korea

References

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Hofherr 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.

Reference Type DERIVED
PMID: 38899206 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9183C00001&attachmentIdentifier=c48c8549-14e6-4641-847e-190626b58aeb&fileName=D9183C00001_Redacted_CSP.pdf&versionIdentifier=

D9183C00001\_Redacted\_CSP

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9183C00001&attachmentIdentifier=95604464-a5a6-49a2-854e-e4c573fd0ea2&fileName=D9183C00001_Redacted_CSR_Synopsis.pdf&versionIdentifier=

D9183C00001\_Redacted\_CSR\_Synopsis

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9183C00001&attachmentIdentifier=f76d1b4f-a37b-4ee1-8117-3091685b8166&fileName=D9183C00001_Redacted_SAP.pdf&versionIdentifier=

D9183C00001\_Redacted\_SAP

Other Identifiers

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D9183C00001

Identifier Type: -

Identifier Source: org_study_id

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