SGLT2 Inhibition in Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-01-30

Brief Summary

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Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.

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Detailed Description

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The Dapagliflozin in Hemodialysis (DAPA-HD) trial is an academic, multicenter, randomized, double-blind, placebo-controlled phase 2 study designed to assess the cardiovascular effects of dapagliflozin in patients with kidney failure undergoing maintenance hemodialysis. A total of 220 patients are randomized 1:1 to dapagliflozin 10 mg once daily or matching placebo for six months, with stratification according to residual urine output. The primary endpoint is the change in left ventricular mass indexed to body surface area, assessed by transthoracic echocardiography after six months of treatment. Secondary endpoints include additional echocardiographic measures, biomarker changes, quality of life, clinical events, and safety outcomes.

Conditions

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Kidney Failure Hemodialysis Diabetes Mellitus, Type 2 Chronic Kidney Disease Left Ventricular Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Dapagliflozin 10 mg

Group Type EXPERIMENTAL

Dapagliflozin 10 MG

Intervention Type DRUG

administered orally once daily

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

administered orally once daily

Interventions

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Dapagliflozin 10 MG

administered orally once daily

Intervention Type DRUG

Placebo

administered orally once daily

Intervention Type DRUG

Other Intervention Names

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Forxiga 10 MG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
* BMI \<45 kg/m2 and stable weight (±5 kg \["dry weight"\]) over the preceding three months
* Interventricular septum width \>11 mm

Exclusion Criteria

* Treatment with SGLT2i within the last 6 months
* Hypersensitivity or Intolerance of SGLT2 inhibitors
* History of Type 1 diabetes mellitus
* History of diabetic ketoacidosis
* Scheduled kidney transplant from a living donor
* Acute coronary syndrome during the last 30 days
* Severe valvular heart disease
* Women of childbearing potential and unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
* Pregnancy
* Breast feeding
* Substance abuse
* Life expectancy \< 1 year
* Other significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No