Trial Outcomes & Findings for Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients (NCT NCT04965935)

Results Overview

SBP

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

52 participants

Primary outcome timeframe

Change from baseline SBP at 12 weeks of treatment

Results posted on

2026-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Dapagliflozin Tablets Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Overall Study STARTED	26	26
Overall Study COMPLETED	26	25
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dapagliflozin Tablets Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Overall Study Adverse Event	0	1

Baseline Characteristics

Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.	Total n=52 Participants Total of all reporting groups
Age, Continuous	57 years n=9 Participants	54 years n=27 Participants	56 years n=267 Participants
Sex: Female, Male Female	4 Participants n=9 Participants	7 Participants n=27 Participants	11 Participants n=267 Participants
Sex: Female, Male Male	22 Participants n=9 Participants	19 Participants n=27 Participants	41 Participants n=267 Participants
Race/Ethnicity, Customized Asian	10 Participants n=9 Participants	8 Participants n=27 Participants	18 Participants n=267 Participants
Race/Ethnicity, Customized Black	1 Participants n=9 Participants	5 Participants n=27 Participants	6 Participants n=267 Participants
Race/Ethnicity, Customized Caucasian	13 Participants n=9 Participants	11 Participants n=27 Participants	24 Participants n=267 Participants
Race/Ethnicity, Customized Latinx	0 Participants n=9 Participants	1 Participants n=27 Participants	1 Participants n=267 Participants
Race/Ethnicity, Customized Other	2 Participants n=9 Participants	1 Participants n=27 Participants	3 Participants n=267 Participants
Time since transplant	9.1 years STANDARD_DEVIATION 11.3 • n=9 Participants	6.7 years STANDARD_DEVIATION 5.9 • n=27 Participants	7.9 years STANDARD_DEVIATION 9 • n=267 Participants
Estimated glomerular filtration rate (eGFR)	62.4 mL/min/1.73 m^2 n=9 Participants	64.7 mL/min/1.73 m^2 n=27 Participants	64.3 mL/min/1.73 m^2 n=267 Participants
Urine albumin-to-creatinine ratio (UACR)	2.5 mg/mmol n=9 Participants	2 mg/mmol n=27 Participants	2.3 mg/mmol n=267 Participants

PRIMARY outcome

Timeframe: Change from baseline SBP at 12 weeks of treatment

SBP

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Systolic Blood Pressure (SBP)	-6.615 mmHg Standard Error 2.084	-3.706 mmHg Standard Error 2.12

SECONDARY outcome

Timeframe: Change from baseline fasting plasma glucose at 12 weeks of treatment

Fasting plasma glucose

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Fasting Plasma Glucose	0.146 mmol/l Standard Error 0.341	0.576 mmol/l Standard Error 0.346

SECONDARY outcome

Timeframe: Change from baseline HbA1c at 12 weeks of treatment

HbA1c

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Glycated Hemoglobin (HbA1c)	-0.112 % of glycated hemoglobin Standard Error 0.115	-0.143 % of glycated hemoglobin Standard Error 0.117

SECONDARY outcome

Timeframe: Change from baseline arterial stiffness at 12 weeks of treatment

Measured using a Sphygmocor device

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Carotid-femoral Pulse Wave Velocity	-0.046 m/s Standard Error 0.527	-0.72 m/s Standard Error 0.536

SECONDARY outcome

Timeframe: Change from baseline systemic vascular resistance at 12 weeks of treatment

Measured using non-invasive cardiac output monitor (NICOM)

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Systemic Vascular Resistance	-76.577 dynes*sec/cm^5 Standard Error 83.311	2.106 dynes*sec/cm^5 Standard Error 86.131

SECONDARY outcome

Timeframe: Change from baseline GFR (based on plasma iohexol clearance) at 12 weeks of treatment

GFR

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Measured GFR	-3.116 mL/min/1.73 m^2 Standard Error 0.99	0.37 mL/min/1.73 m^2 Standard Error 1.01

SECONDARY outcome

Timeframe: Change from baseline proximal tubular natriuresis at 12 weeks of treatment

Measured by fractional excretion of exogenous lithium (FELi)

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Proximal Tubular Natriuresis	5.229 % of lithium excretion Standard Error 2.895	1.662 % of lithium excretion Standard Error 2.895

SECONDARY outcome

Timeframe: Change from baseline albuminuria at 12 weeks of treatment

Albuminuria

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
UACR	-3.25 mg/mmol Standard Error 4.394	-3.134 mg/mmol Standard Error 4.473

SECONDARY outcome

Timeframe: Change from baseline weight at 12 weeks of treatment

Weight

Outcome measures

Outcome measures
Measure	Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 Participants Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Weight	-1.208 kg Standard Error 0.421	0.706 kg Standard Error 0.429

Adverse Events

Dapagliflozin Tablets

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Matching Dapagliflozin Tablets

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dapagliflozin Tablets n=26 participants at risk Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 participants at risk Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Immune system disorders Lupus flare	0.00% 0/26 • 12 weeks	3.8% 1/26 • Number of events 1 • 12 weeks

Other adverse events

Other adverse events
Measure	Dapagliflozin Tablets n=26 participants at risk Patients will be randomized to therapy with dapagliflozin 10mg PO daily for 12 weeks. Dapagliflozin 10 MG Oral Tablet: Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.	Placebo Matching Dapagliflozin Tablets n=26 participants at risk Patients will be randomized to therapy with placebo matching dapagliflozin tablets PO daily for 12 weeks. Placebo Matching Dapagliflozin Oral Tablet: Placebo will be administered for 12 weeks.
Endocrine disorders Mild hypoglycaemic episodes	7.7% 2/26 • Number of events 2 • 12 weeks	7.7% 2/26 • Number of events 2 • 12 weeks

Additional Information

Dr. Sunita Singh

University Health Network

Phone: 4163403240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place