RECRUITING

Dose-Ranging Safety, Tolerability, and Efficacy Study of AZD2373 in Participants With APOL1-Mediated Kidney Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the efficacy and safety of AZD2373 in participants diagnosed with APOL1-Mediated Kidney Disease (AMKD) who are homozygotes or compound heterozygotes for APOL1 high-risk genotypes (G1 and G2). The primary hypothesis to be evaluated is that AZD2373, compared with placebo, will result in a greater reduction in UACR as assessed by the relative change from Baseline in UACR at Week 30.

Official Title

Phase 2b Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of AZD2373 in Participants With APOL1-Mediated Kidney Disease (APPRECIATE)

Quick Facts

Study Start:2025-03-05
Study Completion:2027-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06824987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: Male and female participants aged 18 to 65 years, inclusive at the time of informed consent.
  2. * Participants who have high-risk APOL1 genotype (G1/G1; G1/G2; G2/G2). The screening period can be extended if there are delays related to the shipment, handling, or processing of genotype results.
  3. * A geometric mean UACR ≥ 300 mg/g calculated based on the mean of readings taken from 3 FMV urine samples collected on 3 consecutive days. Since the mean will be assessed for eligibility, any of the 3 readings may fall below 300 mg/g.
  4. * eGFR ≥ 25 mL/min/1.73m2.
  5. * Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  6. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  1. * Participants with diagnosis of Type 1 diabetes mellitus.
  2. * Body Mass Index \> 45 kg/m2.
  3. * SBP \> 180 mmHg/DBP \> 110 mmHg (measured when the participant is considered to be at steady state, and preferably when they have taken their BP medications that same day).
  4. * QTcF \> 470 ms.
  5. * Acute coronary syndrome/Acute myocardial infraction +/- coronary intervention with Percutaneous coronary intervention or Coronary artery bypass grafting within 6 months.
  6. * Transient ischaemic attack/ stroke within 3 months.
  7. * High second to third degree AV block or clinically significant sinus node dysfunction untreated with pacemaker.
  8. * A history of ventricular arrhythmias requiring treatment.
  9. * Participants with Type 2 diabetes mellitus must be excluded if ANY of the following conditions are present:
  10. 1. Current or any past use of insulin
  11. 2. Screening Haemoglobin A1c \> 8.0%
  12. 3. Receiving more than one oral anti-hyperglycaemic agent (excluding SGLT inhibitors which can be taken in addition to one other oral anti-hyperglycaemic agent).
  13. * Participant on kidney replacement therapy (dialysis or kidney transplant) or any other organ transplant.
  14. * History or serologic evidence of autoimmune-mediated glomerular disease including but not limited to: lupus nephritis (positive lupus serology), ANCA associated vasculitis (antineutrophil cytoplasmic antibody), membranous nephropathy (anti-phospholipase A2 receptor antibody or other autoantibody associated with membranous nephropathy), anti-GBM disease (anti-GBM antibody), or IgA nephropathy.
  15. * Another underlying cause of kidney disease that is not associated with APOL1, including but not limited to polycystic kidney disease or, congenital anomalies of the kidney and urinary tract.
  16. * History of a diagnosed coagulopathy, a major unexplained bleeding event, or other high-risk bleeding diathesis.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Alabaster, Alabama, 35007
United States
Research Site
Birmingham, Alabama, 35205
United States
Research Site
Irondale, Alabama, 35210
United States
Research Site
Gardena, California, 90247
United States
Research Site
Los Angeles, California, 90095
United States
Research Site
Northridge, California, 91324
United States
Research Site
Valencia, California, 91355
United States
Research Site
Brandon, Florida, 33511
United States
Research Site
Orlando, Florida, 32808
United States
Research Site
Atlanta, Georgia, 30322
United States
Research Site
Macon, Georgia, 31217
United States
Research Site
Lafayette, Louisiana, 70508
United States
Research Site
Bethesda, Maryland, 20889
United States
Research Site
Roseville, Michigan, 48066
United States
Research Site
Tupelo, Mississippi, 38801
United States
Research Site
Greenville, North Carolina, 27834
United States
Research Site
Winston-Salem, North Carolina, 27103
United States
Research Site
Winston-Salem, North Carolina, 27157
United States
Research Site
Cincinnati, Ohio, 45246
United States
Research Site
Anderson, South Carolina, 29621
United States
Research Site
Spartanburg, South Carolina, 29306
United States
Research Site
Chattanooga, Tennessee, 37404
United States
Research Site
Dallas, Texas, 75234
United States
Research Site
Dallas, Texas, 75235
United States
Research Site
Mesquite, Texas, 75149
United States
Research Site
Pearland, Texas, 77584
United States
Research Site
San Antonio, Texas, 78212
United States
Research Site
Alexandria, Virginia, 22311
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05
Study Completion Date2027-08-30

Study Record Updates

Study Start Date2025-03-05
Study Completion Date2027-08-30

Terms related to this study

Keywords Provided by Researchers

  • APOL1-Mediated Kidney Disease
  • AZD2373

Additional Relevant MeSH Terms

  • APOL1-Mediated Kidney Disease