| Trial ID: | L0234 |
| Source ID: | NCT03190694
|
| Associated Drug: |
Dapagliflozin 10mg
|
| Title: |
Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria
|
| Acronym: |
DIAMOND
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03190694/results
|
| Conditions: |
Chronic Kidney Diseases|Proteinuria
|
| Interventions: |
DRUG: Dapagliflozin 10mg
|
| Outcome Measures: |
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., bioequivalence, 6 weeks | Secondary: Effect of Dapagliflozin 10 mg/d Compared to Placebo on Glomerular Filtration Rate (GFR) Using Iohexol Clearance, bioequivalence, 6 weeks|Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure, bioequivalence, week 0, 3, 6, 12, 15, 18, 24|Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight, bioequivalence, week 0, 3, 6, 12, 15, 18, 24|Effect of Dapagliflozin 10 mg/d Compared to Placebo on 6-keto-Prostaglandin F1 Alpha/Creatinine Ratio, bioequivalence, Baseline, Week 6|Safety of Dapagliflozin vs. Placebo - the Number of Participatns With Hypoglycemic Events and/or Serious Adverse Events, safety, week 0-26|Effect of Dapagliflozin 10 mg/d Compared to Placebo on Adenosine/Creatinine Ratio, bioequivalence, Baseline, Week 6|Effect of Dapagliflozin 10 mg/d Compared to Placebo on Prostaglandin E2/Creatinine Ratio, bioequivalence, Baseline, Week 6|Effect of Dapagliflozin 10 mg/d Compared to Placebo on Thromboxane B2/Creatinine Ratio, bioequivalence, Baseline, Week 6|Effect of Dapagliflozin 10 mg/d Compared to Placebo on PGEM/Creatinine Ratio, bioequivalence, Baseline, Week 6|Effect of Dapagliflozin 10 mg/d Compared to Placebo on NTproBNP, bioequivalence, Baseline (week 0, week 12), Week 6 + 18 (pooled)
|
| Sponsor/Collaborators: |
Sponsor: Hiddo Lambers Heerspink | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
53
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2017-11-12
|
| Completion Date: |
2019-12-01
|
| Results First Posted: |
2024-06-17
|
| Last Update Posted: |
2024-06-17
|
| Locations: |
Nephrology Dept., Vancouver Coastal Health Research Institute, Vancouver, British Columbia, V5Z 1M9, Canada|Division of Nephrology University Health Network, University of Toronto, Toronto, Ontario, M5G 2C4, Canada|Nephrology Unit, University Kebangsaan Malaysia, Kuala Lumpur, 5600, Malaysia|University Malaya Medical Centre, Ward 8TE, Kuala Lumpur, 59100, Malaysia|Dept Internal Medicine, division of Nephrology Hospital Group Twente, Almelo, 7609 PP, Netherlands|Dept.of Nephrology, VU University Medical Center, Amsterdam, 1081 HV, Netherlands|Dept. Nephrology, University Medical Center Groningen, Groningen, 9713 GZ, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT03190694
|
