Trial · NCT03190694
Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria
NCT03190694, Phase 2, Completed, Hiddo Lambers Heerspink; results first posted 2024-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria. Trials, record NCT03190694. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03190694
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria
- NCT number
- NCT03190694
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 53 participants, actual
- Lead sponsor
- Hiddo Lambers Heerspink
- Conditions
- Chronic Kidney Diseases, Proteinuria
- Interventions
- Dapagliflozin 10mg
- First posted
- 2017-06-19
- Last updated
- 2024-06-17
- Other registries' IDs
- eudract:2017-001090-16
- Results first posted
- 2024-06-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment. | 6 weeks | bioequivalence |
| Secondary | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Glomerular Filtration Rate (GFR) Using Iohexol Clearance | 6 weeks | bioequivalence |
| Secondary | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure | week 0, 3, 6, 12, 15, 18, 24 | bioequivalence |
| Secondary | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight | week 0, 3, 6, 12, 15, 18, 24 | bioequivalence |
| Secondary | Effect of Dapagliflozin 10 mg/d Compared to Placebo on 6-keto-Prostaglandin F1 Alpha/Creatinine Ratio | Baseline, Week 6 | bioequivalence |
| Secondary | Safety of Dapagliflozin vs. Placebo - the Number of Participatns With Hypoglycemic Events and/or Serious Adverse Events | week 0-26 | safety |
| Secondary | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Adenosine/Creatinine Ratio | Baseline, Week 6 | bioequivalence |
| Secondary | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Prostaglandin E2/Creatinine Ratio | Baseline, Week 6 | bioequivalence |
| Secondary | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Thromboxane B2/Creatinine Ratio | Baseline, Week 6 | bioequivalence |
| Secondary | Effect of Dapagliflozin 10 mg/d Compared to Placebo on PGEM/Creatinine Ratio | Baseline, Week 6 | bioequivalence |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment. | 6 weeks | % change from baseline | MEAN | |
| SECONDARY | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Glomerular Filtration Rate (GFR) Using Iohexol Clearance | 6 weeks | mL/min per 1.73m2 | MEAN | |
| SECONDARY | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure | week 0, 3, 6, 12, 15, 18, 24 | Due to several missed visits the no. of analyzed participants is not the same for all visits. | mm Hg | MEAN |
| SECONDARY | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight | week 0, 3, 6, 12, 15, 18, 24 | Several participants missed some of their visits | kg | MEAN |
| SECONDARY | Effect of Dapagliflozin 10 mg/d Compared to Placebo on 6-keto-Prostaglandin F1 Alpha/Creatinine Ratio | Baseline, Week 6 | Difference in no. of participants at week 6 due to missed visit | pg/mmol | MEAN |
| SECONDARY | Safety of Dapagliflozin vs. Placebo - the Number of Participatns With Hypoglycemic Events and/or Serious Adverse Events | week 0-26 | participants | NUMBER | |
| SECONDARY | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Adenosine/Creatinine Ratio | Baseline, Week 6 | Difference in no. of participants at week 6 due to missed visit | micromol/mmol | MEAN |
| SECONDARY | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Prostaglandin E2/Creatinine Ratio | Baseline, Week 6 | Difference in no. of participants at week 6 due to missed visit | pg/mmol | MEAN |
| SECONDARY | Effect of Dapagliflozin 10 mg/d Compared to Placebo on Thromboxane B2/Creatinine Ratio | Baseline, Week 6 | Difference in no. of participants at week 6 due to missed visit | pg/mmol | MEAN |
| SECONDARY | Effect of Dapagliflozin 10 mg/d Compared to Placebo on PGEM/Creatinine Ratio | Baseline, Week 6 | Difference in no. of participants at week 6 due to missed visit | pg/mmol | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment. | Dapagliflozin 10mg Tablet | -15.04 | 95% Confidence Interval -25.70 to -2.76 | % change from baseline | |
Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment. | Placebo Matching Dapagliflozin Tablet | -15.80 | 95% Confidence Interval -26.43 to -3.54 | % change from baseline | |
| Effect of Dapagliflozin 10 mg/d Compared to Placebo on Glomerular Filtration Rate (GFR) Using Iohexol Clearance | Dapagliflozin 10mg: Tablet | -6.3 | 95% Confidence Interval -8.0 to -4.6 | mL/min per 1.73m2 | |
| Effect of Dapagliflozin 10 mg/d Compared to Placebo on Glomerular Filtration Rate (GFR) Using Iohexol Clearance | Placebo Matching Dapagliflozin Tablet | 0.3 | 95% Confidence Interval -1.4 to 2.0 | mL/min per 1.73m2 | |
| Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure | Dapagliflozin for 1st 6 Weeks and Matching Placebo for 6 Weeks After 6 Week Washout. | week 0 SBP | 127.4 | Standard Deviation 16.44 | mm Hg |
| Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure | Placebo for the 1st 6 Weeks and Dapagliflozin for 6 Weeks After 6 Week Washout. | week 0 SBP | 124.6 | Standard Deviation 13.1 | mm Hg |
| Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure | Dapagliflozin for 1st 6 Weeks and Matching Placebo for 6 Weeks After 6 Week Washout. | week 3 SBP | 124.3 | Standard Deviation 13.93 | mm Hg |
| Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure | Placebo for the 1st 6 Weeks and Dapagliflozin for 6 Weeks After 6 Week Washout. | week 3 SBP | 121.8 | Standard Deviation 9.9 | mm Hg |
| Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure | Dapagliflozin for 1st 6 Weeks and Matching Placebo for 6 Weeks After 6 Week Washout. | week 6 SBP | 120.4 | Standard Deviation 13.87 | mm Hg |
| Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure | Placebo for the 1st 6 Weeks and Dapagliflozin for 6 Weeks After 6 Week Washout. | week 6 SBP | 123.2 | Standard Deviation 12.27 | mm Hg |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Dapagliflozin 10mg Tablet, Then Placebo | 27 | |
| Period 1 | STARTED | Placebo, Then Dapagliflozin | 26 | |
| Period 1 | COMPLETED | Dapagliflozin 10mg Tablet, Then Placebo | 26 | |
| Period 1 | COMPLETED | Placebo, Then Dapagliflozin | 26 | |
| Period 1 | NOT COMPLETED | Dapagliflozin 10mg Tablet, Then Placebo | 1 | |
| Period 1 | NOT COMPLETED | Placebo, Then Dapagliflozin | 0 | |
| Period 2 (After 6 Weeks Wash-out) | STARTED | Dapagliflozin 10mg Tablet, Then Placebo | 26 | |
| Period 2 (After 6 Weeks Wash-out) | STARTED | Placebo, Then Dapagliflozin | 26 | |
| Period 2 (After 6 Weeks Wash-out) | COMPLETED | Dapagliflozin 10mg Tablet, Then Placebo | 26 | |
| Period 2 (After 6 Weeks Wash-out) | COMPLETED | Placebo, Then Dapagliflozin | 26 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events6
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 | Any adverse event | General disorders | Dapagliflozin 10mg Tablet | 17 | 53 | 17 |
| other | Any adverse event | General disorders | Placebo Matching Dapagliflozin Tablet | 13 | 52 | 13 |
| serious | Cellulitis | Skin and subcutaneous tissue disorders | Dapagliflozin 10mg Tablet | 0 | 53 | 0 |
| serious | Cellulitis | Skin and subcutaneous tissue disorders | Placebo Matching Dapagliflozin Tablet | 1 | 52 | 1 |
| serious | Colon Cancer | Gastrointestinal disorders | Dapagliflozin 10mg Tablet | 1 | 53 | 1 |
| serious | Colon Cancer | Gastrointestinal disorders | Placebo Matching Dapagliflozin Tablet | 0 | 52 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapagliflozin 10mg Tablet | 0 | 53 |
| Total, all-cause mortality | Placebo Matching Dapagliflozin Tablet | 0 | 52 |
| Total, other adverse events | Dapagliflozin 10mg Tablet | 17 | 53 |
| Total, other adverse events | Placebo Matching Dapagliflozin Tablet | 13 | 52 |
| Total, serious adverse events | Dapagliflozin 10mg Tablet | 1 | 53 |
| Total, serious adverse events | Placebo Matching Dapagliflozin Tablet | 1 | 52 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dapagliflozin 10mg Tablet vs Placebo Matching Dapagliflozin Tablet: deaths from any cause | Trial comparisons |
| Dapagliflozin 10mg Tablet vs Placebo Matching Dapagliflozin Tablet: 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/NCT03190694
GET https://conductscience.org/api/trials/v1/NCT03190694/results?page=2