Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02585804
• Date of registration: 22/10/2015
• Prospective Registration: No
• Primary sponsor: University Health Network, Toronto
• Public title: Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects TRANSLATE
• Scientific title: Treating to Reduce Albuminuria and Normalize Hemodynamic Function in Focal ScLerosis With dApagliflozin Trial Effects: "The TRANSLATE Study"
• Date of first enrolment: September 2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02585804
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects diagnosed with FSGS =1 month prior to informed consent

- eGFR=45 ml/min/1.73m2

- Age 18 years or greater

- No history of diabetes

- Body Mass Index (BMI) 18.5 - 45.0 kg/ m2

- Blood pressure = 100/60 at screening

- Stable therapy with either an ACEi or angiotensin II receptor blocker or direct renin
inhibitor for > 1 month

- >30 mg/day and <6 g/day of proteinuria unless the patient is not a candidate for
immunosuppressive therapy

Exclusion Criteria:

- Leukocyte and/or nitrite positive urinalysis that is untreated;

- History of organ transplantation, cancer, liver disease;

- Bariatric surgery or other gastrointestinal surgeries that induce chronic
malabsorption within the past two years;

- Current treatment with systemic corticosteroids, calcineurin inhibitors, or other
immunosuppressant medications;

- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;

- Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not
practising an acceptable method of birth control;

- Participation in another therapeutic trial with an investigational drug within 30 days
prior to informed consent;

- Alcohol or drug abuse within three months prior to informed consent that would
interfere with trial participation or any ongoing clinical condition that would
jeopardize subject safety or study compliance based on investigator judgement;

- Liver disease, defined by serum levels of alanine transaminase, aspartate
transaminase, or alkaline phosphatase >3 x upper limit of normal as determined during
screening;

- Cardiac, lung or peripheral vascular disease or stroke;

- Pancreas, pancreatic islet cells or renal transplant recipient;

- Medical history of cancer or treatment for cancer in the last five years prior to
screening;

- History of allergy or angioedema with RAAS inhibitor exposure;

- Kidney disease due primarily to another condition aside from FSGS;



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis

Intervention(s)

Drug: Dapagliflozin

Primary Outcome(s)

The change in Glomerular Filtration Rate (GFR) After an 8 week treatment with dapagliflozin [Time Frame: Before and after an 8 week treatment with dapagliflozin]

Secondary Outcome(s)

The change in Blood Pressure After an 8 week treatment with dapagliflozin [Time Frame: Before and after 8 weeks of treatment with dapagliflozin]

The change in urinary vasoactive mediators after 8 weeks of treatment with dapagliflozin [Time Frame: Before and after 8 weeks of treatment with dapagliflozin]

The change in albuminuria after 8 weeks of treatment with dapagliflozin [Time Frame: Before and after 8 weeks of treatment with dapagliflozin]

The change in Effective Renal Plasma Flow (ERPF) After an 8 week treatment with dapagliflozin [Time Frame: Before and after an 8 week treatment with dapagliflozin]

Secondary ID(s)

REB# 14-8284-B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Toronto

Toronto General Hospital

AstraZeneca