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

NCT05944016 | Recruiting Phase 3 DMC

• 1 other identifier: UMG DOUBLE PRO-TECT 2023
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Chronic Kidney Failure in Children and Young Adults

Keywords

chronic kidney disease in children; pediatric population; nephroprotective therapy in children; Alport syndrome; type IV collagen disease

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

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

  48 weeks

Secondary Outcomes (5)

• Key secondary efficacy endpoint

  52 weeks

• Key secondary safety endpoint

  52 weeks

• Adverse events (AE) of special interest

  52 weeks

• Adverse events (AE) of special interest

  52 weeks

• Adverse events (AE) of special interest

  52 weeks

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

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

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo therapy.

Drug: Placebo

Interventions

Dapagliflozin DRUG

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

Dapagliflozin

Placebo DRUG

Placebo (standard dose p.o. once daily)

Placebo

Eligibility Criteria

• Age: 10 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Molecular-genetic diagnosis or diagnosis established by kidney biopsy
• Stable RAS blockade as background therapy.
• Signed and dated written informed consent.

You may not qualify if:

• Medical history that might limit the individual's ability to take trial treatments.
• Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.
• eGFR\<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation
• Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).
• Known hypersensitivity or allergy to the investigational products.
• Any previous or current alcohol or drug abuse.
• Participation in another trial with an investigational drug ongoing.
• Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.

Sponsors & Collaborators

• University Hospital Goettingen: lead
• German Research Foundation: collaborator

Study Sites (16)

Universitätsklinikum Heidelberg - Children

Heidelberg, Baden-Württenberg, 69120, Germany

RECRUITING

LMU Klinikum

München, Bavaria, 80336, Germany

RECRUITING

v. Haunersches Kinderhospital

München, Bavaria, 81337, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf - Adults

Hamburg, Hamburg, 20246, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf - Children

Hamburg, Hamburg, 20251, Germany

RECRUITING

Clementine Kinderhospital

Frankfurt am Main, Hesse, 60316, Germany

RECRUITING

University Medicine Goettingen - Adults

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

University Medicine Goettingen - Childrens Hospital

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Universitätsklinik Köln - Adults

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Universitätsklinik Köln - Children

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Universitätsklinik Münster - Adults

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Universitätsklinikum Münster - Children

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Universitätsklinik Leipzig - Children

Leipzig, Saxony, 04103, Germany

RECRUITING

Universitätsklinikum Leipzig - Adults

Leipzig, Saxony, 04103, Germany

RECRUITING

Charite Berlin - Adults

Berlin, State of Berlin, 10117, Germany

RECRUITING

Charite Berlin - Children

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Publications (2)

• Gross O, Boeckhaus J, Weber LT, Heerspink HJL, Simon JF, Ahmed R, Gerst C, Duerr U, Walker F, Tostmann R, Helm J, Asendorf T, Friede T; study group of the German Society of Pediatric Nephrology. Protocol and rationale for a randomized controlled SGLT2 inhibitor trial in paediatric and young adult populations with chronic kidney disease: DOUBLE PRO-TECT Alport. Nephrol Dial Transplant. 2025 Apr 1;40(4):679-687. doi: 10.1093/ndt/gfae180.

  PMID: 39122650 BACKGROUND

• Gross O, Haffner D, Schaefer F, Weber LT. SGLT2 inhibitors: approved for adults and cats but not for children with CKD. Nephrol Dial Transplant. 2024 May 31;39(6):907-909. doi: 10.1093/ndt/gfae029. No abstract available.

  PMID: 38308509 BACKGROUND

MeSH Terms

Conditions

Nephritis, Hereditary

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nephritis; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oliver Gross, MD

  University Medicine Goettingen, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Gross, MD

CONTACT

+4955139; gross.oliver@med.uni-goettingen.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded study using capsules.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Oliver Gross

Model Details: Experimental intervention: Dapagliflozin (standard dose 10 mg p.o. once daily). Control intervention: Placebo therapy.

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 13, 2023
• Study Start: March 25, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Documents will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.
• Access Criteria: IPD will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.

Locations

DE (16)