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FAGOTTO study

Renoprotective effect of canagliflozin derived from test of renal hemodynamics in diabetic kidney disease - FAGOTTO study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041200069
Enrollment
110
Registered
2020-11-27
Start date
2020-12-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 2

Interventions

CANAGLU tablet 100mg /day am B
control

Sponsors

Maruyama Shoichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -patients with stable type 2 diabetes -eGFR(Crteatinine)<= 60mL/min/1.73m2 -patients who are taking renin angiotensin system inhibitors (exclude intolerable or non-adaptive) -older than 18 years -written consent

Exclusion criteria

Exclusion criteria: -SGLT2 inhibitors users within 8 weeks -30<eGFR(Crteatinine) mL/min/1.73m2 -under maintenance dialysis therapy or history of kidney plantation -diuretics users -patients who are taking both ACEi and ARB (renin inhibitor) -active nephritis or kidney disease -obvious steroid diabetes -patients whose ALT and AST levels exceed 2.0 times the facility standard value -heart failure NYHA class 4 -pregnant, or desiring to bear children -inapporopriate for this study as judged by attending investigateor

Design outcomes

Primary

MeasureTime frame
Rate of change in FF (filtration fraction) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group

Secondary

MeasureTime frame
-Change in FF after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Rate of change and change in Cin (glomerular filtration rate by inulin) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Rate of change and change in RPR (renal plasma flow) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Rate of change and change in RBR (renal blood flow) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Rate of change and change in RVR (renal vascular resistance) after 4 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Change in eGFR, HbA1c and albuminuria (proteinuria) after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Change in blood pressure and body weight after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Change in urinary angiotensinogen after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Change in urinary MCP-1, NAG, beta2MG, L-FABP after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Change in serum erythropoietin and hematocrit after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group -Change in serum vasopressin (instead of copeptin), renin, aldosterone, and sodium after 4 and 12 weeks of treatment relative to the baseline between canagliflozin intervention group and control group

Contacts

Public ContactSawako Kato

Nagoya University Graduate School of Medicine

kato07@med.nagoya-u.ac.jp+81-52-744-2192

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026