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

NCT ID: NCT05944016

Last Updated: 2024-12-16

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Failure in Children and Young Adults

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental intervention: Dapagliflozin (standard dose 10 mg p.o. once daily). Control intervention: Placebo therapy.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double-blinded study using capsules.

Study Groups

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Dapagliflozin

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

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

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

Placebo

Placebo therapy.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (standard dose p.o. once daily)

Interventions

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Dapagliflozin

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

Intervention Type DRUG

Placebo

Placebo (standard dose p.o. once daily)

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University Hospital Goettingen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. O. Gross

Prof. Dr. Oliver Gross

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Gross, MD

Role: PRINCIPAL_INVESTIGATOR

University Medicine Goettingen, Germany

Locations

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Universitätsklinikum Heidelberg - Children

Heidelberg, Baden-Württenberg, Germany

Site Status RECRUITING

LMU Klinikum

München, Bavaria, Germany

Site Status RECRUITING

v. Haunersches Kinderhospital

München, Bavaria, Germany

Site Status RECRUITING

Universitätsklinikum Hamburg-Eppendorf - Adults

Hamburg, City state of Hamburg, Germany

Site Status RECRUITING

Universitätsklinikum Hamburg-Eppendorf - Children

Hamburg, City state of Hamburg, Germany

Site Status RECRUITING

Clementine Kinderhospital

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

University Medicine Goettingen - Adults

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

University Medicine Goettingen - Childrens Hospital

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

Universitätsklinik Köln - Adults

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinik Köln - Children

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinik Münster - Adults

Münster, North Rhine-Westphalia, Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Münster - Children

Münster, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinik Leipzig - Children

Leipzig, Saxony, Germany

Site Status RECRUITING

Universitätsklinikum Leipzig - Adults

Leipzig, Saxony, Germany

Site Status RECRUITING

Charite Berlin - Adults

Berlin, State of Berlin, Germany

Site Status RECRUITING

Charite Berlin - Children

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Oliver Gross, MD

Role: CONTACT

Phone: +4955139

Email: [email protected]

Facility Contacts

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Maria Luisa Möller-Winheim

Role: primary

Burkhard Tönshoff, MD

Role: backup

Volker Vielhauer, MD

Role: primary

Hans-Joachim Anders, MD

Role: backup

Bärbel Lange-Sperandio, MD

Role: primary

Klaus Richard, MD

Role: backup

Markus Gödel, MD

Role: primary

Tobias B. Huber, MD

Role: backup

Florian Grahammer, MD

Role: backup

Jun Oh, MD

Role: primary

R. Schild, MD

Role: backup

Claudia Kuss, PhD

Role: primary

Kay Latta, MD

Role: backup

Matthias Hansen, MD

Role: backup

Carmen Scherf

Role: primary

Oliver Gross, MD

Role: backup

Jan Boeckhaus, MD

Role: backup

Carmen Scherf

Role: primary

Matthias Kettwig, MD

Role: backup

Marie Hansen, MD

Role: backup

Polina Todorova, MD

Role: primary

Roman-Ulrich Müller, MD

Role: backup

Thomas Benzing, MD

Role: backup

Stefan Kohl, MD

Role: primary

Lutz Weber, MD

Role: backup

Eva Brand, MD

Role: primary

Hermann-Josef Pavenstädt, MD

Role: backup

Sabine König, MD

Role: primary

Martin Konrad, MD

Role: backup

Jens König, MD

Role: backup

Katalin Dittrich, MD

Role: primary

Nora Liebmann, MD

Role: backup

Jonathan de Fallois, MD

Role: primary

Jan Halbritter, MD

Role: backup

Bastian Krüger, MD

Role: backup

Jan Halbritter, MD

Role: primary

Mira Choi, MD

Role: backup

Markus Schüler, MD

Role: backup

Jutta Gellermann, MD

Role: primary

Julia Thumfart, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 39122650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38308509 (View on PubMed)

Other Identifiers

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UMG DOUBLE PRO-TECT 2023

Identifier Type: -

Identifier Source: org_study_id