A Phase 2/3 interventional study of Dapagliflozin in AKI - Acute Kidney Injury, Biomarkers and Transition to CKD, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Phase 2/3, Interventional, and Prevention
Justification: Studies in recent years have shown that suffering an episode of acute kidney injury (AKI) is an independent risk factor for developing chronic kidney disease (CKD), which is associated with cardiovascular complications, increases medical care costs, and decreases survival. These AKI to ERC transition cases add to the growing number of CKD cases already being seen globally. It is for them that in recent years therapeutic strategies have been sought to reduce or stop this process of transition from AKI to CKD.
Objective: To evaluate the efficacy and safety of the use of dapagliflozin plus standard medical treatment (TMS), compared with only TMS for 21 days, in hospitalized patients with a diagnosis of severe AKI (KDIGO 3) in reducing the incidence of CKD to 18 months of follow-up.
Design: Randomized, single center, open study. 100 hospitalized patients with a diagnosis of AKI KDIGO 3, without previous CKD, will be randomized to receive 10 mg of dapagliflozin every 24 h for 21 days + TMS or only TMS. During their follow-up, baseline blood and urine samples will be taken and at 3, 6, 12 and 18 months. At 18 months, the development of CKD will be assessed using the KDIGO clinical criteria and with the determination of urinary biomarkers (Serpina A3, HSP72, KIM 1 and NGAL).
It is planned to randomize 100 patients, 50 for each arm of the study. The randomization will be 1: 1 based on an open access computer program.
Group 1: Dapagliflozin 10 mg, will be administered orally or by nasogastric tube every 24 h for 21 days.
Group 2: Standard of care strategy, patients will receive the usual treatment for their pathology according to the judgment of their treating physician and the Institutional practices, without receiving any of the interventional drugs.
Eligibility: Adults (aged >18 years) with AKI 3 diagnosis for less than 24 h (KDIGO classification, creatinine level or urine output criteria), hospitalized in general admission floor and/or intensive care unit. AKI diagnosis must be compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 141 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dapagliflozin 10 mg, will be administered orally or by nasogastric tube every 24 h for 21 days.
Drug: Dapagliflozin
Without receiving any of the interventional drugs.
Drug: Dapagliflozin
dapagliflozin is given for 21 days vs standard of care
The primary outcome will be the mean change in urinary Serpin A3 (uSerpinA3) levels 18 months after randomization of the patients.
Time frame: 18 months
GFR at 18 months of randomization calcutated with CKD-EPI creatinine-Cystatin C Equation.
Time frame: 18 months
Urine HSP-72 levels 18 months after randomization of the patients
Time frame: 18 months
Urine NGAL levels 18 months after randomization of the patients
Time frame: 18 months
Urine KIM-1 levels 18 months after randomization of the patients
Time frame: 18 months
Serum Cystatin C levels 18 months after randomization of the patients
Time frame: 18 months
Serum creatinine levels 18 months after randomization of the patients
Time frame: 18 months
Plan to share: No — 117 / 5,000 Resultados de traducción Traducción star_border Once the patients have been recruited and the analysis has been carried out, the complete data will be made available in a supplement
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran