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

NCT02585804 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-01-16

No results posted yet for this study

Summary

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.

Conditions

  • Focal Segmental Glomerulosclerosis

Interventions

DRUG

Dapagliflozin

Oral tablet, 10mg, PO, 8 weeks

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University of Toronto

    collaborator OTHER

  • Toronto General Hospital

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-04-24
Completion
2017-04-24

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02585804 on ClinicalTrials.gov