Trial · NCT04492722

A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease

NCT04492722, Phase 2, Terminated, AstraZeneca; results first posted 2023-12-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease. Trials, record NCT04492722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04492722

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease
NCT number: NCT04492722
Status: Terminated
Phases: Phase 2
Enrollment: 613 participants, actual
Lead sponsor: AstraZeneca
Conditions: Chronic Kidney Disease
Interventions: AZD5718, Dapagliflozin 10 mg, Placebo
First posted: 2020-07-30
Last updated: 2024-12-20
Other registries' IDs: eudract:2020-002263-54
Results first posted: 2023-12-26
Limitations and caveats: Following study termination and reduced scope of the analysis, the PK analysis has not been performed.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20	Week 1 (Baseline) to Week 20	The dose response effect of AZD5718 on urine ACR at 20 weeks was evaluated. Values less than 1 indicate improvement from baseline.
Secondary	Change From Baseline in Reduction of Urine ACR to Week 12	Week 1 (Baseline) to Week 12	The dose response effect of AZD5718 on urine ACR at 12 weeks was evaluated. Values less than 1 indicate improvement from baseline.
Secondary	Number of Participants With Adverse Events and Serious Adverse Events	From Screening (Week -4 to 0) to Week 24	The safety and tolerability profile of AZD5718 treatment was assessed
Secondary	Change From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12	Week 1 (Baseline) to Week 12	The effect of AZD5718 on ambulatory blood pressure was assessed
Secondary	Plasma Concentrations of AZD5718	From Week 2 to Week 20	The PK of AZD5718 after repeated oral dosing for 20 weeks was evaluated
Secondary	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) to Week 12	Week 1 (Baseline), Week 2, Week 4, Week 8, and Week 12	The effect of AZD5718 on renal function was evaluated

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20	Week 1 (Baseline) to Week 20	Per-protocol analysis set consisted of all participants who received the additional treatment with dapagliflozin post-Week 12 and who did not violate the terms of the protocol in a way that could affect the primary efficacy endpoint significantly.	milligram/gram (mg/g)	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in Reduction of Urine ACR to Week 12	Week 1 (Baseline) to Week 12	Per-protocol analysis set consisted of all participants who received the additional treatment with dapagliflozin post-Week 12 and who did not violate the terms of the protocol in a way that could affect the primary efficacy endpoint significantly.	mg/g	GEOMETRIC_MEAN
SECONDARY	Number of Participants With Adverse Events and Serious Adverse Events	From Screening (Week -4 to 0) to Week 24	All participants who were randomised and received any study treatment. Participants were evaluated according to the actual treatment they received. If a participant had received a different treatment dose than randomised throughout the study, they would have been analysed according to the treated dose, not the randomisation dose.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in 24-hours Mean Systolic Blood Pressure to Week 12	Week 1 (Baseline) to Week 12	All participants in the Full Analysis Population who had valid Ambulatory Blood Pressure data for change from baseline analyses.	millimeter mercury (mm Hg)	MEAN
SECONDARY	Plasma Concentrations of AZD5718	From Week 2 to Week 20	All participants in the Full Analysis Population who have at least one detectable AZD5718 plasma concentration measurement post-treatment. The Pharmacokinetic Population was used for all PK analyses. Here n is the number of participants included in the analysis.	nanomoles per liter (nmol/L)	GEOMETRIC_MEAN
SECONDARY	Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) to Week 12	Week 1 (Baseline), Week 2, Week 4, Week 8, and Week 12	Per-protocol analysis set consisted of all participants who received the additional treatment with dapagliflozin post-Week 12.	milliliter/minute/1.73m^2	MEAN

Source ClinicalTrials.gov

Results by group86

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20	AZD5718 Dose 1 + Dapagliflozin 10 mg		0.79	95% Confidence Interval 0.69 to 0.90	milligram/gram (mg/g)
Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20	AZD5718 Dose 2 + Dapagliflozin 10 mg		0.81	95% Confidence Interval 0.70 to 0.92	milligram/gram (mg/g)
Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20	AZD5718 Dose 3 + Dapagliflozin 10 mg		0.77	95% Confidence Interval 0.67 to 0.87	milligram/gram (mg/g)
Change From Baseline in Reduction of Urine Albumin to Creatinine Ratio (ACR) to Week 20	Placebo + Dapagliflozin 10 mg		0.84	95% Confidence Interval 0.73 to 0.95	milligram/gram (mg/g)
Change From Baseline in Reduction of Urine ACR to Week 12	AZD5718 Dose 1 + Dapagliflozin 10 mg		0.94	95% Confidence Interval 0.84 to 1.04	mg/g
Change From Baseline in Reduction of Urine ACR to Week 12	AZD5718 Dose 2 + Dapagliflozin 10 mg		1.03	95% Confidence Interval 0.92 to 1.15	mg/g
Change From Baseline in Reduction of Urine ACR to Week 12	AZD5718 Dose 3 + Dapagliflozin 10 mg		0.96	95% Confidence Interval 0.86 to 1.06	mg/g
Change From Baseline in Reduction of Urine ACR to Week 12	Placebo + Dapagliflozin 10 mg		1.10	95% Confidence Interval 0.99 to 1.22	mg/g
Number of Participants With Adverse Events and Serious Adverse Events	AZD5718 Dose 1 + Dapagliflozin 10 mg	Any AE	82		Participants
Number of Participants With Adverse Events and Serious Adverse Events	AZD5718 Dose 2 + Dapagliflozin 10 mg	Any AE	81		Participants

1 to 10 of 86Source ClinicalTrials.gov

See all 86 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AZD5718 Dose 1 + Dapagliflozin 10 mg	154
Overall Study	STARTED	AZD5718 Dose 2 + Dapagliflozin 10 mg	153
Overall Study	STARTED	AZD5718 Dose 3 + Dapagliflozin 10 mg	153
Overall Study	STARTED	Placebo + Dapagliflozin 10 mg	153
Overall Study	COMPLETED	AZD5718 Dose 1 + Dapagliflozin 10 mg	72
Overall Study	COMPLETED	AZD5718 Dose 2 + Dapagliflozin 10 mg	82
Overall Study	COMPLETED	AZD5718 Dose 3 + Dapagliflozin 10 mg	82
Overall Study	COMPLETED	Placebo + Dapagliflozin 10 mg	82
Overall Study	NOT COMPLETED	AZD5718 Dose 1 + Dapagliflozin 10 mg	82
Overall Study	NOT COMPLETED	AZD5718 Dose 2 + Dapagliflozin 10 mg	71

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events184

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Urinary tract infection	Infections and infestations	AZD5718 Dose 1 + Dapagliflozin 10 mg	8	154	8
other	Urinary tract infection	Infections and infestations	AZD5718 Dose 2 + Dapagliflozin 10 mg	8	152	8
other	Urinary tract infection	Infections and infestations	AZD5718 Dose 3 + Dapagliflozin 10 mg	1	149	2
other	Urinary tract infection	Infections and infestations	Placebo + Dapagliflozin 10 mg	6	153	6
other	Glomerular filtration rate decreased	Investigations	AZD5718 Dose 1 + Dapagliflozin 10 mg	8	154	9
other	Glomerular filtration rate decreased	Investigations	AZD5718 Dose 2 + Dapagliflozin 10 mg	3	152	3
other	Glomerular filtration rate decreased	Investigations	AZD5718 Dose 3 + Dapagliflozin 10 mg	5	149	9
other	Glomerular filtration rate decreased	Investigations	Placebo + Dapagliflozin 10 mg	8	153	10
other	Hyperkalaemia	Metabolism and nutrition disorders	AZD5718 Dose 1 + Dapagliflozin 10 mg	6	154	6
other	Hyperkalaemia	Metabolism and nutrition disorders	AZD5718 Dose 2 + Dapagliflozin 10 mg	7	152	7

1 to 10 of 184Source ClinicalTrials.gov

See all 184 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AZD5718 Dose 1 + Dapagliflozin 10 mg	0	154
Total, all-cause mortality	AZD5718 Dose 2 + Dapagliflozin 10 mg	0	152
Total, all-cause mortality	AZD5718 Dose 3 + Dapagliflozin 10 mg	0	149
Total, all-cause mortality	Placebo + Dapagliflozin 10 mg	1	153
Total, other adverse events	AZD5718 Dose 1 + Dapagliflozin 10 mg	16	154
Total, other adverse events	AZD5718 Dose 2 + Dapagliflozin 10 mg	8	152
Total, other adverse events	AZD5718 Dose 3 + Dapagliflozin 10 mg	9	149
Total, other adverse events	Placebo + Dapagliflozin 10 mg	8	153
Total, serious adverse events	AZD5718 Dose 1 + Dapagliflozin 10 mg	12	154
Total, serious adverse events	AZD5718 Dose 2 + Dapagliflozin 10 mg	8	152

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34805632	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04492722

GET https://conductscience.org/api/trials/v1/NCT04492722/results?page=2

API reference For AI assistants