ProteinuriaPhase 4NCT04534270
Efficacy and Safety of Dapagliflozin in Children With Proteinuria
A Phase 4 study testing Dapagliflozin in people with Proteinuria, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in children with proteinuria. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Proteinuria
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2020to 30 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6 years to 18 years;
- Urinary protein excretion > 0.2g in a 24-hr urine collection;
- eGFR≥60 ml/min/1.73m2;
- No history of diabetes;
- On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for > 1 month;
Who cannot join
- Receiving immunosuppressive therapy within three months prior to enrolment.
- Blood pressure less than 5th percentile of the same gender, age, and height -
- Leukocyte and/or nitrite positive urinalysis that is untreated;
- History of organ transplantation, cancer, liver disease;
- Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit;
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Efficacy and Safety of Dapagliflozin in Non-diabetic Children With Proteinuria
The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in children with proteinuria.
- Conditions
- Proteinuria
- Being tested
- Dapagliflozin
- Keywords
- proteinuria, SGLT2i
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin will be given 5mg per day (weight≤30kg) or 10mg per day (weight>30kg), for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin treatment | Experimental | Not described Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in 24-hr proteinuria after a 4 weeks treatment with dapagliflozin
Urine will be collected for 24 hours and total urinary protein will be detected
Measured: From baseline to weeks 4
Secondary outcomes (2)
The change in 24-hr proteinuria after a 12 weeks treatment with dapagliflozin
Urine will be collected for 24 hours and total urinary protein will be detected
Measured: From baseline to weeks 12
The change in eGFR after a 12 weeks treatment with dapagliflozin
eGFR are repeated measurement data and will be evaluated by Schwartz formula（k*height（cm)/creatinine(umol/L), k=36.5）
Measured: Measured at baseline, weeks 4, weeks 8, weeks 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start6 Jul 2020
- Primary completion30 Dec 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Xu，MD.PhD, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534270
- Sponsor's protocol ID
- EASODICWP.01
- Status last verified
- Feb 2022
- First submitted
- 27 Aug 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dapagliflozin in Non-diabetic Children With Proteinuria
- ClinicalTrials.gov ID
- NCT04534270
- Acronym / sponsor ID
- EASODICWP.01
- Conditions
- Proteinuria
- Keywords
- proteinuria, SGLT2i
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the antiproteinuric effect of Dapagliflozin in children with proteinuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin treatment | Experimental | Drug: Dapagliflozin |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 6 years to 18 years;
- Urinary protein excretion > 0.2g in a 24-hr urine collection;
- eGFR≥60 ml/min/1.73m2;
- No history of diabetes;
- On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for > 1 month;
Key exclusion criteria (6 listed)
- Receiving immunosuppressive therapy within three months prior to enrolment.
- Blood pressure less than 5th percentile of the same gender, age, and height -
- Leukocyte and/or nitrite positive urinalysis that is untreated;
- History of organ transplantation, cancer, liver disease;
- Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin will be given 5mg per day (weight≤30kg) or 10mg per day (weight>30kg), for 12 weeks | Drug | Dapagliflozin treatment |
Primary outcome
The change in 24-hr proteinuria after a 4 weeks treatment with dapagliflozin
Time frame: From baseline to weeks 4
Urine will be collected for 24 hours and total urinary protein will be detected
2 secondary outcomes
The change in 24-hr proteinuria after a 12 weeks treatment with dapagliflozin
Time frame: From baseline to weeks 12
The change in eGFR after a 12 weeks treatment with dapagliflozin
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Proteinuria, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in 24-hr proteinuria after a 4 weeks treatment with dapagliflozin (time frame: From baseline to weeks 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.