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Evolution of proteinuria in renal transplant patients treated with Dapagliflozin for nephroprotection. DAPAGREFFE

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506295-26-00
Acronym
RECHMPL23_0102
Enrollment
70
Registered
2023-10-13
Start date
2023-12-27
Completion date
Unknown
Last updated
2024-08-02

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

Conditions

chronic renal failure

Brief summary

Decrease in albuminuria/creatinuria ratio ≥ 50% from baseline or achievement of albuminuria/creatinuria ratio ≤ 30 mg/g at 6 months after introduction of dapagliflozin

Detailed description

Decrease in albuminuria/creatinuria ratio ≥ 50% from baseline or achievement of albuminuria/creatinuria ratio ≤ 30 mg/g, 3 months after introduction of dapagliflozin, Decrease ≥ 50% in GFR from baseline to M3 et M6, Number of patients with end-stage CKD as defined by dialysis or pre-emptive transplant replacement therapy at M6, Numbers of episodes of acute renal failure defined according to KDIGO criteria (stage I: increase in serum creatinine ≥ 26.52 micromoles/L in 48 hours or increase in serum creatinine of ≥ 1.5 times the initial value in the preceding 7 days, stage II: increase in serum creatinine ≥ 2 times the initial value, stage III: increase in serum creatinine ≥ 3 times the initial value or serum creatinine ≥ 353. 6 mmol/l or need to start extrarenal purification at M3 and M6, Death rate from any cause, Study of interaction with immunosuppressive treatments (residual rate and change in dosage of immunosuppressive treatment) at M3 and M6, Changes in blood pressure, weight and Hba1c from baseline to M3 et M6, Occurrence of infectious side effects, including urinary tract infections, genital mycotic infections, Fournier's gangrene at M3 and M6, Occurrence of metabolic side effects including diabetic ketoacidosis, hypoglycemia, dehydration, hypotension, hydrosodium depletion at M3 and M6, Other adverse reactions associated with dapagliflozin at M3 and M6, Discontinuation of treatment for side effects at M3 and M6

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

University Hospital Of Montpellier
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Decrease in albuminuria/creatinuria ratio ≥ 50% from baseline or achievement of albuminuria/creatinuria ratio ≤ 30 mg/g at 6 months after introduction of dapagliflozin

Secondary

MeasureTime frame
Decrease in albuminuria/creatinuria ratio ≥ 50% from baseline or achievement of albuminuria/creatinuria ratio ≤ 30 mg/g, 3 months after introduction of dapagliflozin, Decrease ≥ 50% in GFR from baseline to M3 et M6, Number of patients with end-stage CKD as defined by dialysis or pre-emptive transplant replacement therapy at M6, Numbers of episodes of acute renal failure defined according to KDIGO criteria (stage I: increase in serum creatinine ≥ 26.52 micromoles/L in 48 hours or increase in serum creatinine of ≥ 1.5 times the initial value in the preceding 7 days, stage II: increase in serum creatinine ≥ 2 times the initial value, stage III: increase in serum creatinine ≥ 3 times the initial value or serum creatinine ≥ 353. 6 mmol/l or need to start extrarenal purification at M3 and M6, Death rate from any cause, Study of interaction with immunosuppressive treatments (residual rate and change in dosage of immunosuppressive treatment) at M3 and M6, Changes in blood pressure, weight and

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026