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

Sponsor
University Health Network, Toronto
Study ID
NCT02585804
Phase
PHASE4
Status
Completed

Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Patients with Focal Segmental Glomerulosclerosis (FSGS) constitute an increasing proportion of the total glomerulonephritis (GN) patient cohort in North America while FSGS is a risk factor for end stage renal failure. Current non-immunological FSGS therapies include the use of angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), to reduce intraglomerular hypertension. Unfortunately, these agents lead to incomplete renal protection. The aim of the current study is to determine whether the addition of novel sodium glucose cotransport-2 inhibitors (SGLT2i) to standard of care leads to reduced intraglomerular pressure and suppression of proteinuria. We hypothesize that combination therapy of SGLT2i drugs and conventional RAASi results in additive renal protective effects in FSGS patients. A further goal is to examine mechanisms of SGLT2 inhibition by measuring renal hemodynamic function and sodium handling. Kidney function will be assessed in FSGS patients before and after an 8 week treatment with SGLT2i dapagliflozin.

Key Dates

Start date
Sep 30, 2015
Status verified
Jan 2018
Primary completion
Apr 24, 2017
Completion
Apr 24, 2017

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin (trade name Farxiga®)
    Oral tablet, 10mg, PO, 8 weeks

Primary Outcome Measure

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 ]

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