An observational study in Alport Syndrome, sponsored by Nanjing University School of Medicine. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Nanjing University School of Medicine · Observational
Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. This study is to evaluate the effects of dapagliflozin on slowing kidney disease progression in patients with Alport syndrome.
38 studies on the registry are indexed under Nephritis, Hereditary; 14 are open to participants now.
This study's enrollment of 222 is below the median of 655 across 17 observational studies indexed under Nephritis, Hereditary.
Browse Nephritis, Hereditary studies →Nanjing University School of Medicine is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Alport syndrome who are at risk for kidney disease progression
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to ACEI/ARB treatment, patients will receive dapagliflozin 10mg once daily for 24 months.
Drug: Dapagliflozin 10mg Tab
Patients will continue ACEI/ARB treatment for 24 months.
Dapagliflozin 10mg daily plus RAS inhibitor
Also known as: Dapagliflozin
Change of eGFR
The change of eGFR from baseline after 24 months of treatment
Time frame: 24 months
Change of proteinuria
The change of proteinuria from baseline after 24 months of treatment
Time frame: 24 months
Progression of kidney disease
The incidence of doubling of serum creatinine, a sustained ≥40% eGFR decline from baseline, or end-stage kidney disease after treatment
Time frame: 24 months
Change of eGFR in different subgroups
The change of eGFR from baseline in patients with different phenotype -genotype after treatment
Time frame: 24 months
Change of proteinuria in different subgroups
The change of proteinuria from baseline in patients with different phenotype -genotype after treatment
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Nanjing University School of Medicine