Trial Outcomes & Findings for Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria (NCT NCT03190694)
NCT ID: NCT03190694
Last Updated: 2024-06-17
Results Overview
bioequivalence
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
53 participants
Primary outcome timeframe
6 weeks
Results posted on
2024-06-17
Participant Flow
Participant milestones
| Measure |
Dapagliflozin 10mg Tablet, Then Placebo
Participants first received Dapagliflozin 10mg tablet for 6 weeks. After a washout period of 6 weeks, they then received Placebo tablet for 6 weeks (matching Dapagliflozin 10mg).
Dapagliflozin 10 mg: Green, plain, diamond shaped, film coated tablet (orally)
Placebo: Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
|
Placebo, Then Dapagliflozin
Participants first received Placebo tablet for 6 weeks. After a washout period of 6 weeks, they then received Dapagliflozin 10mg tablet for 6 weeks.
Placebo: Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Green, plain, diamond shaped, film coated tablet (orally)
|
|---|---|---|
|
Period 1
STARTED
|
27
|
26
|
|
Period 1
COMPLETED
|
26
|
26
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2 (After 6 Weeks Wash-out)
STARTED
|
26
|
26
|
|
Period 2 (After 6 Weeks Wash-out)
COMPLETED
|
26
|
26
|
|
Period 2 (After 6 Weeks Wash-out)
NOT COMPLETED
|
0
|
0
|
|
Wash-out and Follow-up
STARTED
|
26
|
26
|
|
Wash-out and Follow-up
COMPLETED
|
24
|
26
|
|
Wash-out and Follow-up
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria
Baseline characteristics by cohort
| Measure |
Dapagliflozin 10mg Tablet
n=27 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=26 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
mGFR
|
58.9 ml/min/1.73m2
STANDARD_DEVIATION 20.7 • n=5 Participants
|
57.8 ml/min/1.73m2
STANDARD_DEVIATION 25.5 • n=7 Participants
|
58.3 ml/min/1.73m2
STANDARD_DEVIATION 23.0 • n=5 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 10 • n=5 Participants
|
51 years
STANDARD_DEVIATION 16 • n=7 Participants
|
51 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asia
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Proteinuria
|
1170 mg/24h
n=5 Participants
|
1105 mg/24h
n=7 Participants
|
1110 mg/24h
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksbioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=53 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=52 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
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.
|
-15.04 % change from baseline
Interval -25.7 to -2.76
|
-15.80 % change from baseline
Interval -26.43 to -3.54
|
SECONDARY outcome
Timeframe: 6 weeksbioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=53 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=52 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Glomerular Filtration Rate (GFR) Using Iohexol Clearance
|
-6.3 mL/min per 1.73m2
Interval -8.0 to -4.6
|
0.3 mL/min per 1.73m2
Interval -1.4 to 2.0
|
SECONDARY outcome
Timeframe: week 0, 3, 6, 12, 15, 18, 24Population: Due to several missed visits the no. of analyzed participants is not the same for all visits.
bioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=27 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=26 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
week 0 SBP
|
127.4 mm Hg
Standard Deviation 16.44
|
124.6 mm Hg
Standard Deviation 13.1
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
week 3 SBP
|
124.3 mm Hg
Standard Deviation 13.93
|
121.8 mm Hg
Standard Deviation 9.9
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
week 6 SBP
|
120.4 mm Hg
Standard Deviation 13.87
|
123.2 mm Hg
Standard Deviation 12.27
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
week 12 SBP
|
125.6 mm Hg
Standard Deviation 15.86
|
125.2 mm Hg
Standard Deviation 14.02
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
week 15 SBP
|
125.0 mm Hg
Standard Deviation 15.05
|
122.8 mm Hg
Standard Deviation 13.20
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
week 18 SBP
|
123.5 mm Hg
Standard Deviation 10.94
|
120.9 mm Hg
Standard Deviation 16.48
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
week 24 SBP
|
123.6 mm Hg
Standard Deviation 14.90
|
123.9 mm Hg
Standard Deviation 14.67
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
Week 0 DBP
|
77.2 mm Hg
Standard Deviation 8.68
|
75.2 mm Hg
Standard Deviation 7.77
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
Week 3 DBP
|
78.0 mm Hg
Standard Deviation 6.81
|
74.5 mm Hg
Standard Deviation 6.82
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
Week 6 DBP
|
74.5 mm Hg
Standard Deviation 6.8
|
74.4 mm Hg
Standard Deviation 7.84
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
Week 12 DBP
|
77.6 mm Hg
Standard Deviation 7.83
|
74.7 mm Hg
Standard Deviation 9.05
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
Week 15 DBP
|
77.6 mm Hg
Standard Deviation 7.18
|
74.3 mm Hg
Standard Deviation 8.39
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
Week 18 DBP
|
76.6 mm Hg
Standard Deviation 7.44
|
72.7 mm Hg
Standard Deviation 9.3
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Systolic/Diastolic Blood Pressure
Week 24 DBP
|
74.5 mm Hg
Standard Deviation 6.36
|
75.1 mm Hg
Standard Deviation 8.69
|
SECONDARY outcome
Timeframe: week 0, 3, 6, 12, 15, 18, 24Population: Several participants missed some of their visits
bioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=26 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=27 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
Week 0
|
79.646 kg
Standard Deviation 15.5147
|
86.196 kg
Standard Deviation 23.9748
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
Week 3
|
78.892 kg
Standard Deviation 15.8944
|
83.242 kg
Standard Deviation 21.8429
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
Week 6
|
80.419 kg
Standard Deviation 16.1250
|
85.185 kg
Standard Deviation 24.2097
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
Week 12
|
78.712 kg
Standard Deviation 15.0825
|
85.265 kg
Standard Deviation 24.3126
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
Week 15
|
77.046 kg
Standard Deviation 15.1826
|
83.048 kg
Standard Deviation 22.8179
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
Week 18
|
77.488 kg
Standard Deviation 14.9676
|
86.144 kg
Standard Deviation 24.4698
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Body Weight
Week 24
|
77.204 kg
Standard Deviation 12.4649
|
84.163 kg
Standard Deviation 22.2775
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Difference in no. of participants at week 6 due to missed visit
bioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=51 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=50 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on 6-keto-Prostaglandin F1 Alpha/Creatinine Ratio
Baseline
|
0.1170 pg/mmol
Standard Deviation 0.0422
|
0.1167 pg/mmol
Standard Deviation 0.1079
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on 6-keto-Prostaglandin F1 Alpha/Creatinine Ratio
Week 6
|
0.1281 pg/mmol
Standard Deviation 0.0450
|
0.1203 pg/mmol
Standard Deviation 0.0554
|
SECONDARY outcome
Timeframe: week 0-26safety
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=53 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=52 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Safety of Dapagliflozin vs. Placebo - the Number of Participatns With Hypoglycemic Events and/or Serious Adverse Events
Hypoglycemic episode
|
0 participants
|
0 participants
|
|
Safety of Dapagliflozin vs. Placebo - the Number of Participatns With Hypoglycemic Events and/or Serious Adverse Events
Serious adverse event
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Difference in no. of participants at week 6 due to missed visit
bioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=51 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=50 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Adenosine/Creatinine Ratio
Baseline
|
0.2020 micromol/mmol
Standard Deviation 0.1566
|
0.1949 micromol/mmol
Standard Deviation 0.1529
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Adenosine/Creatinine Ratio
Week 6
|
0.2218 micromol/mmol
Standard Deviation 0.1706
|
0.2373 micromol/mmol
Standard Deviation 0.2529
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Difference in no. of participants at week 6 due to missed visit
bioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=51 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=50 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Prostaglandin E2/Creatinine Ratio
Baseline
|
0.1131 pg/mmol
Standard Deviation 0.1498
|
0.0980 pg/mmol
Standard Deviation 0.1034
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Prostaglandin E2/Creatinine Ratio
Week 6
|
0.1702 pg/mmol
Standard Deviation 0.2656
|
0.0946 pg/mmol
Standard Deviation 0.1428
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Difference in no. of participants at week 6 due to missed visit
bioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=51 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=50 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Thromboxane B2/Creatinine Ratio
Baseline
|
0.0921 pg/mmol
Standard Deviation 0.0569
|
0.0963 pg/mmol
Standard Deviation 0.0470
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on Thromboxane B2/Creatinine Ratio
Week 6
|
0.1058 pg/mmol
Standard Deviation 0.1005
|
0.0930 pg/mmol
Standard Deviation 0.0499
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Difference in no. of participants at week 6 due to missed visit
bioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=51 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=50 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on PGEM/Creatinine Ratio
Baseline
|
0.0989 pg/mmol
Standard Deviation 0.0559
|
0.0948 pg/mmol
Standard Deviation 0.0552
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on PGEM/Creatinine Ratio
Week 6
|
0.0965 pg/mmol
Standard Deviation 0.0538
|
0.0963 pg/mmol
Standard Deviation 0.0565
|
SECONDARY outcome
Timeframe: Baseline (week 0, week 12), Week 6 + 18 (pooled)Population: Difference in no. of participants at week 6 due to missed visit
bioequivalence
Outcome measures
| Measure |
Dapagliflozin 10mg Tablet
n=52 Participants
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=50 Participants
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on NTproBNP
Baseline (week 0 + 12)
|
118.8 ng/L
Standard Deviation 151.18
|
125.0 ng/L
Standard Deviation 161.10
|
|
Effect of Dapagliflozin 10 mg/d Compared to Placebo on NTproBNP
Week 6 + 18
|
108.7 ng/L
Standard Deviation 148.74
|
152.6 ng/L
Standard Deviation 277.74
|
Adverse Events
Dapagliflozin 10mg Tablet
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo Matching Dapagliflozin Tablet
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dapagliflozin 10mg Tablet
n=53 participants at risk
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=52 participants at risk
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/53 • From the time of signing the informed consent and throughout the study, including the run-in and wash-out periods, until the follow-up visit 6 weeks after the last treatment period.
|
1.9%
1/52 • Number of events 1 • From the time of signing the informed consent and throughout the study, including the run-in and wash-out periods, until the follow-up visit 6 weeks after the last treatment period.
|
|
Gastrointestinal disorders
Colon Cancer
|
1.9%
1/53 • Number of events 1 • From the time of signing the informed consent and throughout the study, including the run-in and wash-out periods, until the follow-up visit 6 weeks after the last treatment period.
|
0.00%
0/52 • From the time of signing the informed consent and throughout the study, including the run-in and wash-out periods, until the follow-up visit 6 weeks after the last treatment period.
|
Other adverse events
| Measure |
Dapagliflozin 10mg Tablet
n=53 participants at risk
10 mg Green, plain, diamond shaped, film coated tablet (orally)
Dapagliflozin 10mg: Tablet
|
Placebo Matching Dapagliflozin Tablet
n=52 participants at risk
Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
Dapagliflozin 10mg: Tablet
|
|---|---|---|
|
General disorders
Any adverse event
|
32.1%
17/53 • Number of events 17 • From the time of signing the informed consent and throughout the study, including the run-in and wash-out periods, until the follow-up visit 6 weeks after the last treatment period.
|
25.0%
13/52 • Number of events 13 • From the time of signing the informed consent and throughout the study, including the run-in and wash-out periods, until the follow-up visit 6 weeks after the last treatment period.
|
Additional Information
Prof.dr.H.J. Lambers-Heerspink
University Medical Center Groningen
Phone: +31 50 361 7859
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place