Trial Outcomes & Findings for Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients (NCT NCT05748925)
NCT ID: NCT05748925
Last Updated: 2025-04-16
Results Overview
Effect of dapagliflozin compared to placebo on eGFR,24- hour urinary protein
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84 participants
Primary outcome timeframe
one year
Results posted on
2025-04-16
Participant Flow
Participant milestones
| Measure |
Study Group
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
38 years
STANDARD_DEVIATION 9.8 • n=38 Participants
|
36.6 years
STANDARD_DEVIATION 9.6 • n=41 Participants
|
37.3 years
STANDARD_DEVIATION 9.74 • n=79 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=38 Participants
|
34 Participants
n=41 Participants
|
68 Participants
n=79 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=38 Participants
|
7 Participants
n=41 Participants
|
11 Participants
n=79 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body weight (Kg)
|
90 kilograms (kg)
STANDARD_DEVIATION 15 • n=38 Participants
|
78.9 kilograms (kg)
STANDARD_DEVIATION 14 • n=41 Participants
|
84.3 kilograms (kg)
STANDARD_DEVIATION 15.7 • n=79 Participants
|
|
Body mass index
|
33 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 5.7 • n=38 Participants
|
30.6 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 10.5 • n=41 Participants
|
31.9 kilograms per square meter (kg/m²)
STANDARD_DEVIATION 8.5 • n=79 Participants
|
|
Hypertension
|
38 Participants
n=38 Participants
|
37 Participants
n=41 Participants
|
75 Participants
n=79 Participants
|
|
Diabetes
|
11 Participants
n=38 Participants
|
7 Participants
n=41 Participants
|
18 Participants
n=79 Participants
|
PRIMARY outcome
Timeframe: one yearEffect of dapagliflozin compared to placebo on eGFR,24- hour urinary protein
Outcome measures
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year
eGFR Baseline
|
128 mL/min/1.73 m²
Standard Deviation 59.7
|
114 mL/min/1.73 m²
Standard Deviation 51
|
|
Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year
eGFR 12 months
|
115.7 mL/min/1.73 m²
Standard Deviation 48
|
100.3 mL/min/1.73 m²
Standard Deviation 44.5
|
PRIMARY outcome
Timeframe: 1 yearCoronary artery calcification will be measured using non-contrast computed tomography (NCCT). The Agatston score, a standardized method for quantifying coronary calcification, will be used to assess and compare baseline and 1-year follow-up measurements between the dapagliflozin and placebo groups.
Outcome measures
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Cardiovascular Assessment in Two Groups
Coronary calcification 12 months
|
11 Participants
|
1 Participants
|
|
Cardiovascular Assessment in Two Groups
Coronary calcification baseline
|
11 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 1 yearErythropoietin level will be measured in two groups before and after intervention
Outcome measures
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Effect of Dapagliflozin Compared to Placebo on Erythropoietin Level
Erythropoietin level baseline
|
11.3 international units per liter (IU/L)
Standard Deviation 1.4
|
11.6 international units per liter (IU/L)
Standard Deviation 2.1
|
|
Effect of Dapagliflozin Compared to Placebo on Erythropoietin Level
Erythropoietin level 12 months
|
12.4 international units per liter (IU/L)
Standard Deviation 3.5
|
12.8 international units per liter (IU/L)
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 1 yearhepcidin level will be measured in two groups before and after intervention
Outcome measures
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Effect of Dapagliflozin Compared to Placebo on Hepcidin Level
Hepcidin level12 months
|
116 nanograms per milliliter (ng/mL)
Standard Deviation 15
|
128 nanograms per milliliter (ng/mL)
Standard Deviation 63
|
|
Effect of Dapagliflozin Compared to Placebo on Hepcidin Level
Hepcidin level Baseline
|
182 nanograms per milliliter (ng/mL)
Standard Deviation 76
|
198 nanograms per milliliter (ng/mL)
Standard Deviation 74
|
PRIMARY outcome
Timeframe: 1 yearEffect of dapagliflozin compared to placebo on 24- hour urinary protein after 1 year
Outcome measures
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Effect of Dapagliflozin Compared to Placebo on Renal Function
24- hour urinary protein baseline
|
0.6 grams per 24 hours (g/24 hours)
Interval 0.07 to 3.0
|
0.5 grams per 24 hours (g/24 hours)
Interval 0.02 to 4.0
|
|
Effect of Dapagliflozin Compared to Placebo on Renal Function
24- hour urinary protein 12months
|
0.4 grams per 24 hours (g/24 hours)
Interval 0.06 to 3.6
|
0.5 grams per 24 hours (g/24 hours)
Interval 0.02 to 8.0
|
PRIMARY outcome
Timeframe: 1 yearEffect of Dapagliflozin Compared to Placebo on Renal Function on uric acid after 1 year
Outcome measures
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Effect of Dapagliflozin Compared to Placebo on Renal Function
Uric acid baseline
|
6.5 milligrams per deciliter (mg/dL)
Standard Deviation 1.7
|
6.2 milligrams per deciliter (mg/dL)
Standard Deviation 2.1
|
|
Effect of Dapagliflozin Compared to Placebo on Renal Function
Uric acid 12 months
|
5.8 milligrams per deciliter (mg/dL)
Standard Deviation 1.5
|
6.2 milligrams per deciliter (mg/dL)
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 1 yearECCHO will be done before and after intervention
Outcome measures
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Effect of Dapagliflozin Compared to Placebo on ECCHO Parameters
EF baseline
|
64.6 Percentage (%)
Standard Deviation 5.4
|
64.4 Percentage (%)
Standard Deviation 9.3
|
|
Effect of Dapagliflozin Compared to Placebo on ECCHO Parameters
EF 12months
|
64.9 Percentage (%)
Standard Deviation 5.2
|
65.8 Percentage (%)
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 1 yearbody weight will be assessed throughout the study
Outcome measures
| Measure |
Study Group
n=38 Participants
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 Participants
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Effect of Dapagliflozin Compared to Placebo on Body Weight
body weight baseline
|
90 kilo gram
Standard Deviation 15.4
|
78.9 kilo gram
Standard Deviation 14.1
|
|
Effect of Dapagliflozin Compared to Placebo on Body Weight
body weight 12months
|
87 kilo gram
Standard Deviation 14
|
77.9 kilo gram
Standard Deviation 14.3
|
Adverse Events
Study Group
Serious events: 7 serious events
Other events: 4 other events
Deaths: 0 deaths
Control Group
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group
n=38 participants at risk
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 participants at risk
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Renal and urinary disorders
AKI
|
18.4%
7/38 • Number of events 7 • 1 year
|
7.3%
3/41 • Number of events 3 • 1 year
|
Other adverse events
| Measure |
Study Group
n=38 participants at risk
study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye
dapagliflozin: The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.
|
Control Group
n=41 participants at risk
Control group: will receive placebo as add on drug once daily with or without food for one year.
placebo: Control group: will be maintained on their medication
|
|---|---|---|
|
Infections and infestations
UTI
|
10.5%
4/38 • Number of events 4 • 1 year
|
4.9%
2/41 • Number of events 2 • 1 year
|
Additional Information
Nourelsabah Mohamed Elbialy , consaltant nephrology
mansoura urology and nephrology center
Phone: 01065619243
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place