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

NCT05713851 | Recruiting Phase 2 DMC

• 1 other identifier: 4301
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

AKI; Biomarkers; no recovery

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the mean change in urinary Serpin A3 (uSerpinA3) levels 18 months after randomization of the patients.

  18 months

Secondary Outcomes (6)

• GFR at 18 months of randomization calcutated with CKD-EPI creatinine-Cystatin C Equation.

  18 months

• Urine HSP-72 levels 18 months after randomization of the patients

  18 months

• Urine NGAL levels 18 months after randomization of the patients

  18 months

• Urine KIM-1 levels 18 months after randomization of the patients

  18 months

• Serum Cystatin C levels 18 months after randomization of the patients

  18 months

Study Arms (2)

Dapaglifozin group

EXPERIMENTAL

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

Drug: Dapagliflozin

Standard of care

PLACEBO COMPARATOR

Without receiving any of the interventional drugs.

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

dapagliflozin is given for 21 days vs standard of care

Dapaglifozin group; Standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Olynka Vega Vega: collaborator
• Noemi del Toro Cisneros: collaborator
• Miguel Ángel Martínez Rojas: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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, but blood and urinary samples will be taken to determine the biomarkers at the times established in the schedule.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)