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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Goettingen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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