Chronic Kidney Failure in Children and Young AdultsPhase 3DOUBLE_PROTECTNCT05944016
Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
A Phase 3 study testing Dapagliflozin in people with Chronic Kidney Failure in Children and Young Adults, run by University Hospital Goettingen at 16 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 39 years
- Conditions the study is for
- Chronic Kidney Failure in Children and Young Adults
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 16 sitesGermany
- Study dates
- 25 Mar 2024to Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Germany16 sites, 16 recruiting
- Recruiting
Charite Berlin - Adults
Berlin, State of Berlin, 10117
Jan Halbritter, MD
Jan Halbritter, MD
- Recruiting
Charite Berlin - Children
Berlin, State of Berlin, 10117
Jutta Gellermann, MD
Jutta Gellermann, MD
- Recruiting
Universitätsklinik Köln - Adults
Cologne, North Rhine-Westphalia, 50937
Polina Todorova, MD
Roman-Ulrich Müller, MD
- Recruiting
Universitätsklinik Köln - Children
Cologne, North Rhine-Westphalia, 50937
Stefan Kohl, MD
Lutz Weber, MD
- Recruiting
Clementine Kinderhospital
Frankfurt am Main, Hesse, 60316
Claudia Kuss, PhD, c.kuss@ckhf.de
Kay Latta, MD
- Recruiting
University Medicine Goettingen - Adults
Göttingen, Lower Saxony, 37075
Carmen Scherf, carmen.scherf@med.uni-goettingen.de
Oliver Gross, MD
- Recruiting
University Medicine Goettingen - Childrens Hospital
Göttingen, Lower Saxony, 37075
Carmen Scherf, carmen.scherf@med.uni-goettingen.de
Matthias Kettwig, MD
- Recruiting
Universitätsklinikum Hamburg-Eppendorf - Adults
Hamburg, Free and Hanseatic City of Hamburg, 20246
Markus Gödel, MD
Markus Gödel, MD
- Recruiting
Universitätsklinikum Hamburg-Eppendorf - Children
Hamburg, Free and Hanseatic City of Hamburg, 20251
Jun Oh, MD
Jun Oh, MD
- Recruiting
Universitätsklinikum Heidelberg - Children
Heidelberg, Baden-Württenberg, 69120
Maria Luisa Möller-Winheim
Burkhard Tönshoff, MD
- Recruiting
Universitätsklinik Leipzig - Children
Leipzig, Saxony, 04103
Katalin Dittrich, MD
Katalin Dittrich, MD
- Recruiting
Universitätsklinikum Leipzig - Adults
Leipzig, Saxony, 04103
Jonathan de Fallois, MD
Jonathan de Fallois, MD
- Recruiting
LMU Klinikum
München, Bavaria, 80336
Volker Vielhauer, MD
Volker Vielhauer, MD
- Recruiting
v. Haunersches Kinderhospital
München, Bavaria, 81337
Bärbel Lange-Sperandio, MD
Bärbel Lange-Sperandio, MD
- Not yet recruiting
Universitätsklinik Münster - Adults
Münster, North Rhine-Westphalia, 48149
Eva Brand, MD
Hermann-Josef Pavenstädt, MD
- Recruiting
Universitätsklinikum Münster - Children
Münster, North Rhine-Westphalia, 48149
Sabine König, MD
Martin Konrad, MD
About this study
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
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.
- Being tested
- Dapagliflozin, Placebo
- Keywords
- chronic kidney disease in children, pediatric population, nephroprotective therapy in children, Alport syndrome, type IV collagen disease
- Medical subject headings
- Nephritis, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin (standard dose 10 mg p.o. once daily)
PlaceboDrug
Placebo (standard dose p.o. once daily)
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin (standard dose 10 mg p.o. once daily). Receives: Drug: Dapagliflozin |
| Placebo | Placebo comparator | Placebo therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks
Measured: 48 weeks
Secondary outcomes (5)
Key secondary efficacy endpoint
Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment)
Measured: 52 weeks
Key secondary safety endpoint
Adverse events (including serious adverse events)
Measured: 52 weeks
Adverse events (AE) of special interest
(a) Ketoacidosis or symptomatic hypoglycemic event.
Measured: 52 weeks
Adverse events (AE) of special interest
(b) Hyperkalemia (potassium levels ≥15% of the upper normal limit)
Measured: 52 weeks
Adverse events (AE) of special interest
(c) Decline in eGFR of ≥ 30% relative from baseline eGFR.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start25 Mar 2024
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Failure in Children and Young AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental intervention: Dapagliflozin (standard dose 10 mg p.o. once daily). Control intervention: Placebo therapy.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Goettingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Prof. Dr. O. Gross, University Hospital Goettingen
- Investigators
- Oliver Gross, MD, Principal investigator, University Medicine Goettingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944016
- Sponsor's protocol ID
- UMG DOUBLE PRO-TECT 2023
- Other IDs
- 2023-508502-18-00, 2023
- Acronym
- DOUBLE_PROTECT
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.
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;40(4):679-687. doi: 10.1093/ndt/gfae180.
PubMed 39122650Gross 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.
PubMed 38308509