Dapaglifozin to Avoid Acute Kindey Injury (AKI) to Chronic Kidney Disease (CKD) Transition: DAKI-CKD Study

NCT ID: NCT05713851

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-01-01

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).

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 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.

Conditions

AKI - Acute Kidney Injury; Biomarkers; Transition to CKD; CKD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dapaglifozin group

Dapagliflozin 10 mg, will be administered orally or by nasogastric tube every 24 h for 21 days.

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

dapagliflozin is given for 21 days vs standard of care

Standard of care

Without receiving any of the interventional drugs.

Group Type: PLACEBO_COMPARATOR

Dapagliflozin

Intervention Type: DRUG

dapagliflozin is given for 21 days vs standard of care

Interventions

Dapagliflozin

dapagliflozin is given for 21 days vs standard of care

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• CKD Stage 3b (KDIGO) or more, renal transplant, urinary tract obstruction, thrombotic microangiopathy, acute glomerulopathy, cardiac arrest without awakening, oncological diagnosis with a life expectancy of less than 5 years, use of norephinephrine >0.30 mcg/kg/min for 6 h or more, use of two vasopressors, PaO2/FiO2 ratio <150, Type 1 DM, fasting for more than 48 h, previous inclusion in other study, pregnant or breastfeeding woman.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Olynka Vega Vega

UNKNOWN

Sponsor Role: collaborator

Noemi del Toro Cisneros

UNKNOWN

Sponsor Role: collaborator

Miguel Ángel Martínez Rojas

UNKNOWN

Sponsor Role: collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Norma Bobadilla

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Facility Contacts

Olynka Vega-Vega, MD

Role: primary

olynkavega@hotmail.com

+52 1 55 4803 9428

Norma A Bobadilla Sandoval, PhD

Role: backup

nab@iibiomedicas.unam.mx

+52 1 55 55 5487 0900

Other Identifiers

4301

Identifier Type: -

Identifier Source: org_study_id