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A Phase 2a Diabetic Kidney Disease Study

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ClinicalTrials.gov Identifier: NCT04170543
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: MEDI3506 Drug: Placebo Phase 2

Detailed Description:
This is a Phase 2a, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, PK, and immunogenicity of MEDI3506 in adult subjects with DKD defined as subjects with type 2 diabetes mellitus (T2DM) and an estimated glomerular filtration rate (eGFR) value of 30-75 mL/min/1.73 m2 who meet all eligibility criteria. Approximately 168 subjects, from 2-3 countries will be randomized to MEDI3506 dose 1 or dose 2, or placebo during a treatment period of 24 weeks. The primary objective is change in UACR from baseline at 24 weeks. Secondary objectives include evaluating safety, PK and the incidence of ADA during the treatment period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible subjects will be randomized to receive MEDI3506 or placebo as follows: Group 1: MEDI3506 Dose 1. Group 2: MEDI3506 Dose 2. Group 3 and 4: Placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Phase 2a Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects With Diabetic Kidney Disease
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : March 8, 2021
Estimated Study Completion Date : March 8, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
MEDI3506 Dose 1
Drug: MEDI3506
Dose 1 and Dose 2

Experimental: Group 2
MEDI3506 Dose 2
Drug: MEDI3506
Dose 1 and Dose 2

Placebo Comparator: Group 3 and Group 4
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline in urine albumin:creatinine ratio (UACR) [ Time Frame: baseline to Day 169 ]
    Change in UACR compared to placebo


Secondary Outcome Measures :
  1. Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 265 days (38 weeks) approximately. ]
    TEAEs from time of informed consent to Visit 12 or the date of last contact

  2. Incidence of treatment emergent serious adverse events (TESAEs) [ Time Frame: Up to 265 days (38 weeks) approximately ]
    TESAEs from time of informed consent to Visit 12 or the date of last contact

  3. Evaluation of the PK profile of MEDI3506 [ Time Frame: Day 1, 15, 29, 85, 141, 169, 230 ]
    MEDI3506 serum PK concentrations

  4. Incidence of positive antibodies to MEDI3506 [ Time Frame: Day 1, 15, 29, 85, 141, 169, 230 ]
    Development of anti-drug antibodies (ADAs) to MEDI3506



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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion criteria:

  1. Written informed consent
  2. DKD defined as the diagnosis of T2DM and
  3. eGFR 30-75 mL/min and
  4. Micro- or macro-albuminuria defined as 100-3000 mg albumin/g creatinine
  5. Stable blood pressure (BP) and on stable doses of ACEi or ARB as tolerated

Key Exclusion Criteria

  1. Diagnosis of CKD other than diabetic renal disease
  2. Abnormal laboratory findings during screening including: abnormal liver function tests; serum potassium > 5.5 mmol/L that cannot be adjusted to values ≤ 5.5 mmol/L by appropriate management; hemoglobin (Hb) A1c > 10.5%; B-type natriuretic peptide (BNP) level > 200 pg/mL at screening
  3. History of clinically significant heart disease; New York Heart Association Class 3 or 4 or history of recent hospitalization for heart failure; history of unstable arrhythmias
  4. Any of the following concomitant conditions including history of inflammatory bowel disease; anticipated dialysis or renal transplantation; prior malignancy other than non-melanoma skin cancer or cervical cancer in situ; the presence of significant infection; history of herpes zoster, hepatitis B, hepatitis C, or HIV); history or evidence of active tuberculosis (TB) infection or one of the risk factors for tuberculosis; history of severe allergic reactions; or 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
  5. Live or attenuated virus vaccination within 28 days of screening
  6. Ongoing use of any biologic drug and/or small molecule targeting the immune system
  7. Pregnancy, intention to become pregnant during the course of the study, or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04170543


Contacts
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Contact: AstraZeneca Clinical S. Marvin Study Information Center, M.D. 1-877-240-9479 ext 301-398-3347 information.center@astrazeneca.com

Locations
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United States, California
Research Site Recruiting
Sacramento, California, United States, 95821
Research Site Not yet recruiting
Sacramento, California, United States, 95821
United States, Florida
Research Site Recruiting
Miami, Florida, United States, 33015
United States, Hawaii
Research Site Recruiting
Honolulu, Hawaii, United States, 96814
United States, Illinois
Research Site Not yet recruiting
Chicago, Illinois, United States, 60643
United States, Texas
Research Site Not yet recruiting
Houston, Texas, United States, 77004
Research Site Not yet recruiting
San Antonio, Texas, United States, 78212
United States, West Virginia
Research Site Not yet recruiting
Morgantown, West Virginia, United States, 26506
Japan
Research Site Not yet recruiting
Chuo-ku, Japan, 103-0027
Research Site Not yet recruiting
Koshigaya-shi, Japan, 343-8577
Research Site Not yet recruiting
Osaka-shi, Japan, 530-0001
Research Site Not yet recruiting
Tsuchiura-shi, Japan, 300-0028
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04170543     History of Changes
Other Study ID Numbers: D9183C00001
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases