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

Primary Purpose

AKI - Acute Kidney Injury, Biomarkers, Transition to CKD

Status
Recruiting
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Dapagliflozin
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for AKI - Acute Kidney Injury focused on measuring AKI, Biomarkers, no recovery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador ZubiránRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapaglifozin group

Standard of care

Arm Description

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

Without receiving any of the interventional drugs.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

GFR at 18 months of randomization calcutated with CKD-EPI creatinine-Cystatin C Equation.
Urine HSP-72 levels 18 months after randomization of the patients
Urine NGAL levels 18 months after randomization of the patients
Urine KIM-1 levels 18 months after randomization of the patients
Serum Cystatin C levels 18 months after randomization of the patients
Serum creatinine levels 18 months after randomization of the patients

Full Information

First Posted
January 26, 2023
Last Updated
February 28, 2023
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Olynka Vega Vega, Noemi del Toro Cisneros, Miguel Ángel Martínez Rojas
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1. Study Identification

Unique Protocol Identification Number
NCT05713851
Brief Title
Dapaglifozin to Avoid Acute Kindey Injury (AKI) to Chronic Kidney Disease (CKD) Transition: DAKI-CKD Study
Acronym
DAKI-CKD
Official Title
Potential Use of Dapaglifozin to Avoid Acute Kindey Injury (AKI) to Chronic Kidney Disease (CKD) Transition: DAKI-CKD Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Olynka Vega Vega, Noemi del Toro Cisneros, Miguel Ángel Martínez Rojas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AKI - Acute Kidney Injury, Biomarkers, Transition to CKD, CKD
Keywords
AKI, Biomarkers, no recovery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapaglifozin group
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg, will be administered orally or by nasogastric tube every 24 h for 21 days.
Arm Title
Standard of care
Arm Type
Placebo Comparator
Arm Description
Without receiving any of the interventional drugs.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
dapagliflozin is given for 21 days vs standard of care
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
GFR at 18 months of randomization calcutated with CKD-EPI creatinine-Cystatin C Equation.
Time Frame
18 months
Title
Urine HSP-72 levels 18 months after randomization of the patients
Time Frame
18 months
Title
Urine NGAL levels 18 months after randomization of the patients
Time Frame
18 months
Title
Urine KIM-1 levels 18 months after randomization of the patients
Time Frame
18 months
Title
Serum Cystatin C levels 18 months after randomization of the patients
Time Frame
18 months
Title
Serum creatinine levels 18 months after randomization of the patients
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olynka Vega-Vega, MD
Phone
+52 1 55 4803 9428
Email
olynkavega@hotmail.com
First Name & Middle Initial & Last Name & Degree
Norma A Bobadilla Sandoval, PhD
Phone
+52 1 55 55 5487 0900
Email
nab@iibiomedicas.unam.mx
First Name & Middle Initial & Last Name & Degree
Norma A Bobadilla Sandoval, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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

Learn more about this trial

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

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