Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Failure in Children and Young Adults. Basic parameters: 10 years — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DOUBLE PRO-TECT Alport: a Confirmatory, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Dapagliflozin on the Progression of Chronic Kidney Disease in Adolescents and Young Adult Patients with Alport Syndrome
Overview
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.
Interventions
- Drug Dapagliflozin
Dapagliflozin (standard dose 10 mg p.o. once daily) - Drug Placebo
Placebo (standard dose p.o. once daily)
Primary outcome measures
- Primary endpoint [Time frame: 48 weeks]
Secondary outcome measures (5)
- Key secondary efficacy endpoint [Time frame: 52 weeks]
- Key secondary safety endpoint [Time frame: 52 weeks]
- Adverse events (AE) of special interest [Time frame: 52 weeks]
- Adverse events (AE) of special interest [Time frame: 52 weeks]
- Adverse events (AE) of special interest [Time frame: 52 weeks]
Eligibility criteria
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
- Molecular-genetic diagnosis or diagnosis established by kidney biopsy
- Stable RAS blockade as background therapy.
- Signed and dated written informed consent.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Germany · 16 centers
- Universitätsklinikum Heidelberg - Children — Heidelberg
- LMU Klinikum — München
- v. Haunersches Kinderhospital — München
- Universitätsklinikum Hamburg-Eppendorf - Adults — Hamburg
- Universitätsklinikum Hamburg-Eppendorf - Children — Hamburg
- Clementine Kinderhospital — Frankfurt am Main
- University Medicine Goettingen - Adults — Göttingen
- University Medicine Goettingen - Childrens Hospital — Göttingen
- … and 8 more centers
Publications
- 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;4 PMID 39122650
- 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
Identifiers
NCT: NCT05944016 · UMG DOUBLE PRO-TECT 2023