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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05713851
Recruitment Status : Recruiting
First Posted : February 6, 2023
Last Update Posted : March 2, 2023
Sponsor:
Collaborators:
Olynka Vega Vega
Noemi del Toro Cisneros
Miguel Ángel Martínez Rojas
Information provided by (Responsible Party):
Norma Bobadilla, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Description
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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).


Condition or disease Intervention/treatment Phase
AKI - Acute Kidney Injury Biomarkers Transition to CKD CKD Drug: Dapagliflozin Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Potential Use of Dapaglifozin to Avoid Acute Kindey Injury (AKI) to Chronic Kidney Disease (CKD) Transition: DAKI-CKD Study
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dapaglifozin group
Dapagliflozin 10 mg, will be administered orally or by nasogastric tube every 24 h for 21 days.
 Drug: Dapagliflozin
dapagliflozin is given for 21 days vs standard of care
Placebo Comparator: Standard of care
Without receiving any of the interventional drugs.
 Drug: Dapagliflozin
dapagliflozin is given for 21 days vs standard of care


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. GFR at 18 months of randomization calcutated with CKD-EPI creatinine-Cystatin C Equation. [ Time Frame: 18 months ]
  2. Urine HSP-72 levels 18 months after randomization of the patients [ Time Frame: 18 months ]
  3. Urine NGAL levels 18 months after randomization of the patients [ Time Frame: 18 months ]
  4. Urine KIM-1 levels 18 months after randomization of the patients [ Time Frame: 18 months ]
  5. Serum Cystatin C levels 18 months after randomization of the patients [ Time Frame: 18 months ]
  6. Serum creatinine levels 18 months after randomization of the patients [ Time Frame: 18 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05713851


Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Mexico, 14080
Contact: Olynka Vega-Vega, MD    +52 1 55 4803 9428    olynkavega@hotmail.com   
Contact: Norma A Bobadilla Sandoval, PhD    +52 1 55 55 5487 0900    nab@iibiomedicas.unam.mx   
Principal Investigator: Norma A Bobadilla Sandoval, PhD         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Olynka Vega Vega
Noemi del Toro Cisneros
Miguel Ángel Martínez Rojas
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Norma Bobadilla, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT05713851    
Other Study ID Numbers: 4301
First Posted: February 6, 2023    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norma Bobadilla, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
AKI
Biomarkers
no recovery
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Wounds and Injuries
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
 Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs