- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04170543
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Buenos Aires, Argentina, C1056ABJ
- Research Site
-
Buenos Aires, Argentina, 1425DES
- Research Site
-
Buenos Aires, Argentina, C1429BWN
- Research Site
-
Caba, Argentina, C1425AGC
- Research Site
-
Caba, Argentina, C1120AAC
- Research Site
-
Caba, Argentina, C1128AAF
- Research Site
-
Cordoba, Argentina, X5000AAW
- Research Site
-
Corrientes, Argentina, W3400AMZ
- Research Site
-
Mar del Plata, Argentina, 7600
- Research Site
-
Pergamino, Argentina, B2700LDK
- Research Site
-
Ramos Mejía, Argentina, B1704ETD
- Research Site
-
Rosario, Argentina, S2000DNM
- Research Site
-
San Luis, Argentina, D5700CTA
- Research Site
-
San Nicolás, Argentina, B2900DMH
- Research Site
-
San Vicente, Argentina, 5006
- Research Site
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2H 2G4
- Research Site
-
Red Deer, Alberta, Canada, T4N 6V7
- Research Site
-
-
Ontario
-
Brampton, Ontario, Canada, L6T 0G1
- Research Site
-
Brampton, Ontario, Canada, L6S 0S9
- Research Site
-
Concord, Ontario, Canada, L4K 4M2
- Research Site
-
Etobicoke, Ontario, Canada, M9R 4E1
- Research Site
-
Toronto, Ontario, Canada, M4G 3E8
- Research Site
-
-
-
-
-
Concepción, Chile
- Research Site
-
Nunoa, Chile, 8520398
- Research Site
-
Santiago, Chile
- Research Site
-
Santiago, Chile, 8320000
- Research Site
-
Santiago, Chile, 7500021
- Research Site
-
Santiago, Chile, 7500710
- Research Site
-
Victoria, Chile
- Research Site
-
-
-
-
-
Chuo-ku, Japan, 103-0027
- Research Site
-
Fukuoka-shi, Japan, 815-8555
- Research Site
-
Ise-shi, Japan, 516-8512
- Research Site
-
Kisarazu-shi, Japan, 292-8535
- Research Site
-
Koshigaya-shi, Japan, 343-8577
- Research Site
-
Nagano-shi, Japan, 388-8004
- Research Site
-
Nagoya, Japan, 451-8511
- Research Site
-
Nishinomiya-Shi, Japan, 662-0918
- Research Site
-
Osaka-shi, Japan, 530-0001
- Research Site
-
Osaka-shi, Japan, 558-8558
- Research Site
-
Sayama-Shi, Japan
- Research Site
-
-
-
-
-
Gangnam-Gu, Korea, Republic of, 6273
- Research Site
-
Goyang-si, Korea, Republic of, 10444
- Research Site
-
Jongno-gu, Korea, Republic of, 110-746
- Research Site
-
Seongbuk-Gu, Korea, Republic of, 02841
- Research Site
-
Seoul, Korea, Republic of, 06351
- Research Site
-
Suwon, Korea, Republic of, 16499
- Research Site
-
Wonju-si, Korea, Republic of, 26426
- Research Site
-
-
-
-
-
Piura, Peru
- Research Site
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- Research Site
-
Huntsville, Alabama, United States, 35805
- Research Site
-
-
Arizona
-
Mesa, Arizona, United States, 85210
- Research Site
-
-
California
-
Alhambra, California, United States, 91801
- Research Site
-
Glendale, California, United States, 91204
- Research Site
-
Granada Hills, California, United States, 91344
- Research Site
-
Huntington Park, California, United States, 90255
- Research Site
-
Northridge, California, United States, 91324
- Research Site
-
Sacramento, California, United States, 95821
- Research Site
-
San Diego, California, United States, 92123
- Research Site
-
San Dimas, California, United States, 91773
- Research Site
-
Vacaville, California, United States, 95687
- Research Site
-
-
Florida
-
Fleming Island, Florida, United States, 32003
- Research Site
-
Hialeah, Florida, United States, 33016
- Research Site
-
Jacksonville, Florida, United States, 32204
- Research Site
-
Miami, Florida, United States, 33015
- Research Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30338
- Research Site
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96814
- Research Site
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- Research Site
-
Chicago, Illinois, United States, 60643
- Research Site
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Research Site
-
-
Kansas
-
Manhattan, Kansas, United States, 66502
- Research Site
-
Topeka, Kansas, United States, 66606
- Research Site
-
Wichita, Kansas, United States, 67214
- Research Site
-
-
Michigan
-
Flint, Michigan, United States, 48504
- Research Site
-
-
Nevada
-
Henderson, Nevada, United States, 89014
- Research Site
-
Las Vegas, Nevada, United States, 89129
- Research Site
-
-
New Jersey
-
Berlin, New Jersey, United States, 08009
- Research Site
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Research Site
-
Greensboro, North Carolina, United States, 27408
- Research Site
-
Greenville, North Carolina, United States, 27834
- Research Site
-
Morehead City, North Carolina, United States, 28557
- Research Site
-
-
Ohio
-
Maumee, Ohio, United States, 43537
- Research Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73116
- Research Site
-
-
Pennsylvania
-
Bethlehem, Pennsylvania, United States, 18017
- Research Site
-
-
Rhode Island
-
East Providence, Rhode Island, United States, 02915
- Research Site
-
-
South Carolina
-
Columbia, South Carolina, United States, 29203
- Research Site
-
-
Tennessee
-
Memphis, Tennessee, United States, 38119
- Research Site
-
-
Texas
-
Cypress, Texas, United States, 77429
- Research Site
-
Houston, Texas, United States, 77004
- Research Site
-
Houston, Texas, United States, 77079
- Research Site
-
Katy, Texas, United States, 77450
- Research Site
-
San Antonio, Texas, United States, 78229
- Research Site
-
San Antonio, Texas, United States, 78251
- Research Site
-
San Antonio, Texas, United States, 78212
- Research Site
-
-
Utah
-
Saint George, Utah, United States, 84790
- Research Site
-
-
Virginia
-
Burke, Virginia, United States, 22015
- Research Site
-
-
Washington
-
Tacoma, Washington, United States, 98405
- Research Site
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
MEDI3506 Dose 1 plus Dapagliflozin (Day 85 to Day 168).
|
Dose 1, Dose 2, Dose 3, Dose 4
Dapagliflozin 10 mg
|
Experimental: Group 2
MEDI3506 Dose 2 plus Dapagliflozin (Day 85 to Day 168).
|
Dose 1, Dose 2, Dose 3, Dose 4
Dapagliflozin 10 mg
|
Experimental: Group 3
MEDI3506 Dose 3 plus Dapagliflozin (Day 85 to Day 168).
|
Dose 1, Dose 2, Dose 3, Dose 4
Dapagliflozin 10 mg
|
Experimental: Group 4
MEDI3506 Dose 4 plus Dapagliflozin (Day 85 to Day 168).
|
Dose 1, Dose 2, Dose 3, Dose 4
Dapagliflozin 10 mg
|
Placebo Comparator: Group 5
Placebo (volume matched) plus Dapagliflozin (Day 85 to Day 168).
|
Placebo
Dapagliflozin 10 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine albumin:creatinine ratio (UACR)
Time Frame: Baseline to Day 169 (24 weeks)
|
Change compared to placebo
|
Baseline to Day 169 (24 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability by assessment of adverse events
Time Frame: Visit 1 (Screening) to Day 230 (End of Study)
|
To assess the number Treatment Emergent Adverse events (TEAEs), Serious Adverse Events (SAEs), Treatment Emergent Adverse Events of Special Interest (AESIs)
|
Visit 1 (Screening) to Day 230 (End of Study)
|
Immunogenicity of MEDI3506
Time Frame: Day 1 to Day 230
|
Anti-drug antibodies (ADAs) incidence throughout the study
|
Day 1 to Day 230
|
UACR
Time Frame: At Day 169, baseline to Day 85 (12 weeks) or Day 85 to Day 169
|
Proportion of subjects with > 30%, > 40% and > 50% at Day 169, change in UACR from baseline to Day 85 and change from Day 85 to Day 169
|
At Day 169, baseline to Day 85 (12 weeks) or Day 85 to Day 169
|
Safety and tolerability by clinical laboratory evaluations
Time Frame: Visit 1(Screening) to End of study
|
|
Visit 1(Screening) to End of study
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcome: Geometric mean of MEDI3506.
Time Frame: Time Frame: Measurement at screening, at Day time frame: measurement at day 29, 85 and 169
|
Percentage change from baseline in geometric mean of MEDI3506 concentration in plasma.
|
Time Frame: Measurement at screening, at Day time frame: measurement at day 29, 85 and 169
|
Secondary Outcome: Concentration in plasma
Time Frame: Measurement at screening, at Day 29, Day 85 and Day 169
|
Plasma concentration of MEDI3506 concentration in plasma
|
Measurement at screening, at Day 29, Day 85 and Day 169
|
Secondary Outcome: Anti-drug antibodies (ADAs)
Time Frame: Measurement at Day 1, Day 29, Day 85 and Day 169
|
Anti-drug antibodies (ADAs) during the treatment period and follow-up period
|
Measurement at Day 1, Day 29, Day 85 and Day 169
|
Secondary Outcome: Percentage change from baseline
Time Frame: Measurement at screening, Day 1, Day 29, Day 85
|
Percentage change from baseline in levels of biomarker of inflammation and fibrosis relevant to DKD progression including but not limited to: hsCRP, sST2, IL-33, MCP-1, TNFR1/2
|
Measurement at screening, Day 1, Day 29, Day 85
|
Safety and tolerability by assessment of vital signs
Time Frame: Measurement at Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Vital sign: Systolic blood pressure (SBP)
|
Measurement at Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Safety and tolerability by assessment of vital signs
Time Frame: Measurement at Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Vital sign: Diastolic blood pressure (DBP)
|
Measurement at Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Safety and tolerability by assessment of vital signs
Time Frame: Measurement at Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Vital sign: Heart rate and respiratory rate
|
Measurement at Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Safety and tolerability by assessment of vital signs
Time Frame: Measurement Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Vital sign: Oral body temperature
|
Measurement Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Safety and tolerability by assessment of vital signs
Time Frame: Measurement at Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Number of subjects with an ECG determined to be abnormal and clinically significant
|
Measurement at Day - 3, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
|
Safety and tolerability by assessment of vital signs
Time Frame: Measurement at Day -3 and Day 169
|
Number of subjects with clinically significant changes in left ventricular ejection fraction
|
Measurement at Day -3 and Day 169
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Diabetic Nephropathies
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Sodium-Glucose Transporter 2 Inhibitors
- Dapagliflozin
Other Study ID Numbers
- D9183C00001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Kidney Disease
-
University of UtahNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingHemodialysis | Kidney Disease, Chronic | Kidney Failure | Dialysis | Diabetic | End-stage Kidney Disease | Kidney Dysfunction | Non-diabeticUnited States
-
Eli Lilly and CompanyTerminatedDiabetic Nephropathy | Diabetic Kidney Disease | Diabetic GlomerulosclerosisIsrael, Hungary, United States, Australia, France, Czechia, Puerto Rico
-
Chinese PLA General HospitalBeijing Friendship Hospital; Guang'anmen Hospital of China Academy of Chinese... and other collaboratorsRecruitingDiabetic Kidney DiseaseChina
-
Omar Tarek ElfarargiNot yet recruiting
-
Second Affiliated Hospital, School of Medicine,...Second Affiliated Hospital of Wenzhou Medical University; Lishui Country People...Not yet recruitingEstablishment and Clinical Validation of a New Technique for Early Diagnosis of Diabetic NephropathyDiabetes Mellitus | Diabetic Kidney Disease | Biomarkers | Early Diagnosis
-
Fayoum UniversityCairo UniversityNot yet recruitingSGLT2i Kideny Protection Against Contrast in Diabetic Kidney
-
Mayo ClinicRegenerative Medicine MinnesotaTerminatedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type 1 | Diabetic Kidney Disease | Diabetic Nephropathies | Chronic Kidney Disease | Kidney Failure | Diabetic Nephropathy Type 2 | Kidney InsufficiencyUnited States
-
CSL BehringCompletedDiabetic Kidney Disease (DKD)United States, Australia, New Zealand, Puerto Rico, Canada, Israel
-
Renalytix AI, Inc.RecruitingDiabetic Kidney Disease | Chronic Kidney Disease, Stage 3 (Moderate) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1United States
-
Renalytix AI, Inc.Mount Sinai Hospital, New YorkRecruitingChronic Kidney Diseases | Diabetic Kidney DiseaseUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States