Actively Recruiting
Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Led by University Hospital Goettingen · Updated on 2024-12-16
102
Participants Needed
16
Research Sites
140 weeks
Total Duration
On this page
Sponsors
U
University Hospital Goettingen
Lead Sponsor
G
German Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Phase 3 Clinical Trial with Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Early stage chronic kidney disease with confirmed Alport syndrome at screening
- Adolescents 10 to under 18 years with albuminuria (UACR ≥ 300 mg/g creatinine) and eGFR ≥ 30 ml/min/1.73 m2
- Adults 18 to under 40 years with albuminuria (UACR ≥ 500 mg/g creatinine) and eGFR ≥ 60 ml/min/1.73 m2
- Diagnosis confirmed by molecular genetics or kidney biopsy
- Stable renin-angiotensin system blockade therapy
- Signed and dated informed consent
You will not qualify if you...
- Medical history limiting ability to take trial treatments
- Treatment with any SGLT2 inhibitor within 4 weeks before screening
- eGFR below 60 ml/min/1.73 m2, dialysis requirement, or kidney transplant
- Uncontrolled high blood pressure above 145/95 mmHg
- Known allergy to study drugs
- Current or past alcohol or drug abuse
- Participation in another investigational drug trial
- Women who are pregnant, nursing, or not using acceptable birth control
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Universitätsklinikum Heidelberg - Children
Heidelberg, Baden-Württenberg, Germany, 69120
Actively Recruiting
2
LMU Klinikum
München, Bavaria, Germany, 80336
Actively Recruiting
3
v. Haunersches Kinderhospital
München, Bavaria, Germany, 81337
Actively Recruiting
4
Universitätsklinikum Hamburg-Eppendorf - Adults
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
5
Universitätsklinikum Hamburg-Eppendorf - Children
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20251
Actively Recruiting
6
Clementine Kinderhospital
Frankfurt am Main, Hesse, Germany, 60316
Actively Recruiting
7
University Medicine Goettingen - Adults
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
8
University Medicine Goettingen - Childrens Hospital
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
9
Universitätsklinik Köln - Adults
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
10
Universitätsklinik Köln - Children
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
11
Universitätsklinik Münster - Adults
Münster, North Rhine-Westphalia, Germany, 48149
Not Yet Recruiting
12
Universitätsklinikum Münster - Children
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
13
Universitätsklinik Leipzig - Children
Leipzig, Saxony, Germany, 04103
Actively Recruiting
14
Universitätsklinikum Leipzig - Adults
Leipzig, Saxony, Germany, 04103
Actively Recruiting
15
Charite Berlin - Adults
Berlin, State of Berlin, Germany, 10117
Actively Recruiting
16
Charite Berlin - Children
Berlin, State of Berlin, Germany, 10117
Actively Recruiting
Research Team
O
Oliver Gross, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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