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Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients (DOUBLE_PROTECT)

Primary Purpose

Chronic Kidney Failure in Children and Young Adults

Status
Not yet recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Dapagliflozin
Placebo
Sponsored by
Prof. Dr. O. Gross
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Failure in Children and Young Adults focused on measuring chronic kidney disease in children, pediatric population, nephroprotective therapy in children, Alport syndrome, type IV collagen disease

Eligibility Criteria

10 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Key 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. Key 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.

Sites / Locations

  • Universitätsklinikum Heidelberg - Children
  • LMU Klinikum
  • v. Haunersches Kinderhospital
  • Clementine Kinderhospital
  • University Medicine Goettingen - Adults
  • University Medicine Goettingen - Childrens Hospital
  • Universitätsklinik Köln - Adults
  • Universitätsklinik Köln - Children
  • Universitätsklinik Münster - Adults
  • Universitätsklinikum Münster - Children
  • Universitätsklinik Leipzig - Children
  • Universitätsklinikum Leipzig - Adults
  • Charite Berlin - Adults
  • Charite Berlin - Children
  • Universitätsklinikum Hamburg-Eppendorf - Adults
  • Universitätsklinikum Hamburg-Eppendorf - Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapagliflozin

Placebo

Arm Description

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

Placebo therapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Key secondary efficacy endpoint
Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment)
Key secondary safety endpoint
Adverse events (including serious adverse events)
Adverse events (AE) of special interest
(a) Ketoacidosis or symptomatic hypoglycemic event.
Adverse events (AE) of special interest
(b) Hyperkalemia (potassium levels ≥15% of the upper normal limit)
Adverse events (AE) of special interest
(c) Decline in eGFR of ≥ 30% relative from baseline eGFR.

Full Information

First Posted
July 1, 2023
Last Updated
August 4, 2023
Sponsor
Prof. Dr. O. Gross
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05944016
Brief Title
Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients
Acronym
DOUBLE_PROTECT
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. O. Gross
Collaborators
German Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Experimental intervention: Dapagliflozin (standard dose 10 mg p.o. once daily). Control intervention: Placebo therapy.
Masking
ParticipantInvestigator
Masking Description
double-blinded study using capsules.
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
Dapagliflozin (standard dose 10 mg p.o. once daily).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo therapy.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin
Intervention Description
Dapagliflozin (standard dose 10 mg p.o. once daily)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (standard dose p.o. once daily)
Primary Outcome Measure Information:
Title
Primary endpoint
Description
Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Key secondary efficacy endpoint
Description
Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment)
Time Frame
52 weeks
Title
Key secondary safety endpoint
Description
Adverse events (including serious adverse events)
Time Frame
52 weeks
Title
Adverse events (AE) of special interest
Description
(a) Ketoacidosis or symptomatic hypoglycemic event.
Time Frame
52 weeks
Title
Adverse events (AE) of special interest
Description
(b) Hyperkalemia (potassium levels ≥15% of the upper normal limit)
Time Frame
52 weeks
Title
Adverse events (AE) of special interest
Description
(c) Decline in eGFR of ≥ 30% relative from baseline eGFR.
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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. Key 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Gross, MD
Phone
+4955139
Ext
60488
Email
gross.oliver@med.uni-goettingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Gross, MD
Organizational Affiliation
University Medicine Goettingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Heidelberg - Children
City
Heidelberg
State/Province
Baden-Württenberg
ZIP/Postal Code
69120
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Luisa Möller-Winheim
First Name & Middle Initial & Last Name & Degree
Burkhard Tönshoff, MD
Facility Name
LMU Klinikum
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
v. Haunersches Kinderhospital
City
München
State/Province
Bayern
ZIP/Postal Code
81337
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bärbel Lange-Sperandio, MD
First Name & Middle Initial & Last Name & Degree
Bärbel Lange-Sperandio, MD
First Name & Middle Initial & Last Name & Degree
Klaus Richard, MD
Facility Name
Clementine Kinderhospital
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60316
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Kuss, PhD
Email
c.kuss@ckhf.de
First Name & Middle Initial & Last Name & Degree
Kay Latta, MD
First Name & Middle Initial & Last Name & Degree
Matthias Hansen, MD
Facility Name
University Medicine Goettingen - Adults
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Scherf
Email
carmen.scherf@med.uni-goettingen.de
First Name & Middle Initial & Last Name & Degree
Oliver Gross, MD
First Name & Middle Initial & Last Name & Degree
Jan Boeckhaus, MD
Facility Name
University Medicine Goettingen - Childrens Hospital
City
Göttingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Scherf
Email
carmen.scherf@med.uni-goettingen.de
First Name & Middle Initial & Last Name & Degree
Matthias Kettwig, MD
First Name & Middle Initial & Last Name & Degree
Marie Hansen, MD
Facility Name
Universitätsklinik Köln - Adults
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Polina Todorova, MD
First Name & Middle Initial & Last Name & Degree
Roman-Ulrich Müller, MD
First Name & Middle Initial & Last Name & Degree
Thomas Benzing, MD
First Name & Middle Initial & Last Name & Degree
Polina Todorova, MD
Facility Name
Universitätsklinik Köln - Children
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kohl, MD
First Name & Middle Initial & Last Name & Degree
Lutz Weber, MD
First Name & Middle Initial & Last Name & Degree
Stefan Kohl, MD
Facility Name
Universitätsklinik Münster - Adults
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Brand, MD
First Name & Middle Initial & Last Name & Degree
Hermann-Josef Pavenstädt, MD
First Name & Middle Initial & Last Name & Degree
Eva Brand, MD
Facility Name
Universitätsklinikum Münster - Children
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine König, MD
First Name & Middle Initial & Last Name & Degree
Martin Konrad, MD
First Name & Middle Initial & Last Name & Degree
Sabine König, MD
First Name & Middle Initial & Last Name & Degree
Jens König, MD
Facility Name
Universitätsklinik Leipzig - Children
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katalin Dittrich, MD
First Name & Middle Initial & Last Name & Degree
Katalin Dittrich, MD
First Name & Middle Initial & Last Name & Degree
Nora Liebmann, MD
Facility Name
Universitätsklinikum Leipzig - Adults
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan de Fallois, MD
First Name & Middle Initial & Last Name & Degree
Jonathan de Fallois, MD
First Name & Middle Initial & Last Name & Degree
Jan Halbritter, MD
First Name & Middle Initial & Last Name & Degree
Bastian Krüger, MD
Facility Name
Charite Berlin - Adults
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Halbritter, MD
First Name & Middle Initial & Last Name & Degree
Jan Halbritter, MD
First Name & Middle Initial & Last Name & Degree
Mira Choi, MD
First Name & Middle Initial & Last Name & Degree
Markus Schüler, MD
Facility Name
Charite Berlin - Children
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jutta Gellermann, MD
First Name & Middle Initial & Last Name & Degree
Jutta Gellermann, MD
First Name & Middle Initial & Last Name & Degree
Julia Thumfart, MD
Facility Name
Universitätsklinikum Hamburg-Eppendorf - Adults
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Gödel, MD
First Name & Middle Initial & Last Name & Degree
Markus Gödel, MD
First Name & Middle Initial & Last Name & Degree
Tobias B. Huber, MD
First Name & Middle Initial & Last Name & Degree
Florian Grahammer, MD
Facility Name
Universitätsklinikum Hamburg-Eppendorf - Children
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Oh, MD
First Name & Middle Initial & Last Name & Degree
Jun Oh, MD
First Name & Middle Initial & Last Name & Degree
R. Schild, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.

Learn more about this trial

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

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