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

December 11, 2024 updated by: Prof. Dr. O. Gross, University Hospital Goettingen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charite Berlin - Adults
        • Contact:
          • Jan Halbritter, MD
        • Contact:
          • Mira Choi, MD
        • Contact:
          • Markus Schüler, MD
      • Berlin, Germany, 10117
        • Recruiting
        • Charite Berlin - Children
        • Contact:
          • Jutta Gellermann, MD
        • Contact:
          • Julia Thumfart, MD
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf - Adults
        • Contact:
          • Markus Gödel, MD
        • Contact:
          • Tobias B. Huber, MD
        • Contact:
          • Florian Grahammer, MD
      • Hamburg, Germany, 20251
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf - Children
        • Contact:
          • Jun Oh, MD
        • Contact:
          • R. Schild, MD
    • Baden-Württenberg
      • Heidelberg, Baden-Württenberg, Germany, 69120
        • Recruiting
        • Universitätsklinikum Heidelberg - Children
        • Contact:
          • Maria Luisa Möller-Winheim
        • Contact:
          • Burkhard Tönshoff, MD
    • Bayern
      • München, Bayern, Germany, 80336
        • Recruiting
        • LMU Klinikum
        • Contact:
          • Volker Vielhauer, MD
        • Contact:
          • Hans-Joachim Anders, MD
      • München, Bayern, Germany, 81337
        • Recruiting
        • v. Haunersches Kinderhospital
        • Contact:
          • Bärbel Lange-Sperandio, MD
        • Contact:
          • Klaus Richard, MD
    • Hessen
      • Frankfurt, Hessen, Germany, 60316
        • Recruiting
        • Clementine Kinderhospital
        • Contact:
        • Contact:
          • Kay Latta, MD
        • Contact:
          • Matthias Hansen, MD
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
      • Göttingen, Lower Saxony, Germany, 37075
        • Recruiting
        • University Medicine Goettingen - Childrens Hospital
        • Contact:
        • Contact:
          • Matthias Kettwig, MD
        • Contact:
          • Marie Hansen, MD
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Recruiting
        • Universitätsklinik Köln - Adults
        • Contact:
          • Polina Todorova, MD
        • Contact:
          • Roman-Ulrich Müller, MD
        • Contact:
          • Thomas Benzing, MD
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Recruiting
        • Universitätsklinik Köln - Children
        • Contact:
          • Stefan Kohl, MD
        • Contact:
          • Lutz Weber, MD
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Not yet recruiting
        • Universitätsklinik Münster - Adults
        • Contact:
          • Eva Brand, MD
        • Contact:
          • Hermann-Josef Pavenstädt, MD
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Children
        • Contact:
          • Sabine König, MD
        • Contact:
          • Martin Konrad, MD
        • Contact:
          • Jens König, MD
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitätsklinik Leipzig - Children
        • Contact:
          • Katalin Dittrich, MD
        • Contact:
          • Nora Liebmann, MD
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig - Adults
        • Contact:
          • Jan Halbritter, MD
        • Contact:
          • Jonathan de Fallois, MD
        • Contact:
          • Bastian Krüger, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

    1. Molecular-genetic diagnosis or diagnosis established by kidney biopsy
    2. Stable RAS blockade as background therapy.
    3. Signed and dated written informed consent.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin
Dapagliflozin (standard dose 10 mg p.o. once daily).
Drug: Dapagliflozin
Dapagliflozin (standard dose 10 mg p.o. once daily)
Placebo Comparator: Placebo
Placebo therapy.
Drug: Placebo
Placebo (standard dose p.o. once daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint
Time Frame: 48 weeks
Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks
48 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Goettingen

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Oliver Gross, MD, University Medicine Goettingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 1, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMG DOUBLE PRO-TECT 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.

IPD Sharing Time Frame

Documents will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.

IPD Sharing Access Criteria

IPD will be shared after end of study on request and with valid IRB-vote and data protection protocol by applicant.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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