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AZD5718 for Chronic Kidney Disease

Phase 2
Waitlist Available
Led By Hiddo J. L. Heerspink
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female adults, >= 18 years of age at study entry.
Body weight within 50-150 kg and body mass index within the range 18 to 45 kg/m^2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 (baseline), week 2, week 4, week 8, and week 12
Awards & highlights

Study Summary

This study is evaluating whether a drug may help slow the progression of kidney disease.

Eligible Conditions
  • Chronic Kidney Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 (baseline), week 2, week 4, week 8, and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 (baseline), week 2, week 4, week 8, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20
Secondary outcome measures
Change From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) to Week 12
Change From Baseline in Reduction of Urine ACR to Week 12
+2 more

Side effects data

From 2020 Phase 2 trial • 129 Patients • NCT03317002
16%
Nasopharyngitis
16%
Dyspnoea
8%
Dizziness
4%
Pancreatitis acute
4%
Non-cardiac chest pain
4%
Acute myocardial infarction
4%
Diarrhoea
4%
Nausea
4%
Headache
4%
Angina pectoris
4%
Contusion
4%
Chest pain
4%
Fatigue
4%
Anxiety
4%
Ventricular fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD5718 (50 mg)
AZD5718 (200 mg)
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: AZD5718 Dose 3 + Dapagliflozin 10 mgExperimental Treatment2 Interventions
Participants will receive once daily oral dose 3 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
Group II: AZD5718 Dose 2 + Dapagliflozin 10 mgExperimental Treatment2 Interventions
Participants will receive once daily oral dose 2 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
Group III: AZD5718 Dose 1 + Dapagliflozin 10 mgExperimental Treatment2 Interventions
Participants will receive once daily oral dose 1 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
Group IV: Placebo + Dapagliflozin 10 mgPlacebo Group2 Interventions
Participants will receive once daily oral dose of placebo matched to AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10 mg
2015
Completed Phase 4
~18150
AZD5718
2021
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,593,173 Total Patients Enrolled
ParexelIndustry Sponsor
303 Previous Clinical Trials
100,213 Total Patients Enrolled
George Clinical Pty LtdIndustry Sponsor
13 Previous Clinical Trials
20,679 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
2020. "A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04492722.
~136 spots leftby Apr 2025
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