Trial · NCT03036150
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
NCT03036150, Phase 3, Completed, AstraZeneca; results first posted 2021-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease. Trials, record NCT03036150. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03036150
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
- NCT number
- NCT03036150
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,304 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Chronic Kidney Disease
- Interventions
- Dapagliflozin, Placebo
- First posted
- 2017-01-30
- Last updated
- 2021-07-07
- Other registries' IDs
- eudract:2016-003896-24
- Results first posted
- 2021-07-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. | Up to 38.2 months | End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table. |
| Secondary | Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death. | Up to 38.2 months | End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table. |
| Secondary | Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure. | Up to 38.2 months | The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table. |
| Secondary | Time to Death From Any Cause. | Up to 38.2 months | The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. | Up to 38.2 months | For the primary endpoint the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death. | Up to 38.2 months | For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure. | Up to 38.2 months | For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Death From Any Cause. | Up to 38.2 months | For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. | Dapagliflozin | 197 | Participants | ||
| Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. | Placebo | 312 | Participants | ||
| Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death. | Dapagliflozin | 142 | Participants | ||
| Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death. | Placebo | 243 | Participants | ||
| Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure. | Dapagliflozin | 100 | Participants | ||
| Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure. | Placebo | 138 | Participants | ||
| Time to Death From Any Cause. | Dapagliflozin | 101 | Participants | ||
| Time to Death From Any Cause. | Placebo | 146 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapagliflozin | 2,152 | |
| Overall Study | STARTED | Placebo | 2,152 | |
| Overall Study | COMPLETED | Dapagliflozin | 2,142 | |
| Overall Study | COMPLETED | Placebo | 2,147 | |
| Overall Study | NOT COMPLETED | Dapagliflozin | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events1,380
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 | Diarrhoea | Gastrointestinal disorders | Dapa 10 mg | 45 | 2,149 | 56 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 41 | 2,149 | 46 |
| other | Oedema peripheral | General disorders | Dapa 10 mg | 54 | 2,149 | 56 |
| other | Oedema peripheral | General disorders | Placebo | 63 | 2,149 | 75 |
| other | Nasopharyngitis | Infections and infestations | Dapa 10 mg | 92 | 2,149 | 136 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 81 | 2,149 | 118 |
| other | Urinary tract infection | Infections and infestations | Dapa 10 mg | 78 | 2,149 | 102 |
| other | Urinary tract infection | Infections and infestations | Placebo | 79 | 2,149 | 96 |
| other | Glomerular filtration rate decreased | Investigations | Dapa 10 mg | 39 | 2,149 | 45 |
| other | Glomerular filtration rate decreased | Investigations | Placebo | 61 | 2,149 | 67 |
1 to 10 of 1,380Source ClinicalTrials.gov
See all 1,380 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapa 10 mg | 107 | 2,152 |
| Total, all-cause mortality | Placebo | 159 | 2,152 |
| Total, other adverse events | Dapa 10 mg | 479 | 2,149 |
| Total, other adverse events | Placebo | 500 | 2,149 |
| Total, serious adverse events | Dapa 10 mg | 633 | 2,149 |
| Total, serious adverse events | Placebo | 729 | 2,149 |
Source ClinicalTrials.gov
Papers35
The papers the trial lists on ClinicalTrials.gov.
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dapagliflozin vs Placebo: Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure. | Trial comparisons |
| Dapagliflozin vs Placebo: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death. | Trial comparisons |
| Dapagliflozin vs Placebo: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. | Trial comparisons |
| Dapa 10 mg vs Placebo: deaths from any cause | Trial comparisons |
| Dapagliflozin vs Placebo: Time to Death From Any Cause. | Trial comparisons |
| Dapa 10 mg vs Placebo: serious adverse events | Trial comparisons |
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.
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/NCT03036150
GET https://conductscience.org/api/trials/v1/NCT03036150/events?page=2