Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients

NCT05944016 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Goettingen

Phase

Phase 3

Started

2024-03-25

Last updated

2024-12-16

Condition(s) studied

Chronic Kidney Failure in Children and Young Adults

Investigational drug(s) / intervention(s)

Dapagliflozin →Placebo

Dapagliflozin: Dapagliflozin (standard dose 10 mg p.o. once daily)

Placebo: Placebo (standard dose p.o. once daily)

Study summary

Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.

Eligibility

Sex

ALL

Min age

10 Years

Max age

39 Years

Healthy volunteers

Key inclusion criteria: Early stages of CKD with established diagnosis of Alport syndrome at visit 1 (screening) * adolescents ≥ 10 to \< 18 years with albuminuria (UACR ≥ 300mg/g creatinine) AND * eGFR ≥ 30 ml/min/1.73 m2 OR * adults ≥ 18 to \< 40 years with albuminuria (UACR ≥ 500mg/g creatinine) AND * eGFR ≥ 60 ml/min/1.73 m2 1. Molecular-genetic diagnosis or diagnosis established by kidney biopsy 2. Stable RAS blockade as background therapy. 3. Signed and dated written informed consent. Key exclusion criteria: 1. Medical history that might limit the individual's ability to take trial treatments. 2. Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1. 3. eGFR\<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation 4. Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg). 5. Known hypersensitivity or allergy to the investigational products. 6. Any previous or current alcohol or drug abuse. 7. Participation in another trial with an investigational drug ongoing. 8. Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.

Primary outcome measure(s)

Primary endpoint — 48 weeks
Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks

Trial sites (16)

Facility	City	Region	Status
Universitätsklinikum Heidelberg - Children	Heidelberg	Baden-Württenberg	Recruiting
LMU Klinikum	München	Bavaria	Recruiting
v. Haunersches Kinderhospital	München	Bavaria	Recruiting
Universitätsklinikum Hamburg-Eppendorf - Adults	Hamburg	Free and Hanseatic City of Hamburg	Recruiting
Universitätsklinikum Hamburg-Eppendorf - Children	Hamburg	Free and Hanseatic City of Hamburg	Recruiting
Clementine Kinderhospital	Frankfurt am Main	Hesse	Recruiting
University Medicine Goettingen - Adults	Göttingen	Lower Saxony	Recruiting
University Medicine Goettingen - Childrens Hospital	Göttingen	Lower Saxony	Recruiting
Universitätsklinik Köln - Adults	Cologne	North Rhine-Westphalia	Recruiting
Universitätsklinik Köln - Children	Cologne	North Rhine-Westphalia	Recruiting
Universitätsklinik Münster - Adults	Münster	North Rhine-Westphalia	Not Yet Recruiting
Universitätsklinikum Münster - Children	Münster	North Rhine-Westphalia	Recruiting
Universitätsklinik Leipzig - Children	Leipzig	Saxony	Recruiting
Universitätsklinikum Leipzig - Adults	Leipzig	Saxony	Recruiting
Charite Berlin - Adults	Berlin	State of Berlin	Recruiting
Charite Berlin - Children	Berlin	State of Berlin	Recruiting

On this site

📄 Farxiga (dapagliflozin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05944016 on ClinicalTrials.gov ↗ ← All trials in Germany