Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05713851
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-01-26
Brief Title:
Dapaglifozin to Avoid Acute Kindey Injury AKI to Chronic Kidney Disease CKD Transition DAKI-CKD Study
Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Organization:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study Overview
Official Title:
Potential Use of Dapaglifozin to Avoid Acute Kindey Injury AKI to Chronic Kidney Disease CKD Transition DAKI-CKD Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAKI-CKD
Brief Summary:
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
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
Detailed Description:
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 andor intensive care unit AKI diagnosis must be compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression
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 andor intensive care unit AKI diagnosis must be compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None