ProteinuriaPhase 4NCT04531397
Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease
A Phase 4 study testing ACEI treatment and Dapagliflozin+ACEI treatment in people with Proteinuria and Chronic Kidney Diseases, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Proteinuria, Chronic Kidney Diseases
- What is being tested?
- ACEI treatment and Dapagliflozin+ACEI treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 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 > 200 mg in a 24-hr urine collection；
- Without any immunosuppressant medications such as corticosteroids, CNIs and so on；
- Estimated GFR ≥ 60 ml/min/1.73m2（estimated with Schwartz formula）；
- No history of diabetes；
- On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for > 1 month；
- Willing to sign informed consent.
Who cannot join
- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis;
- Blood pressure less than 5th percentile of the same gender, age, and height;
- Uncontrolled urinary tract infection at screening;
- At risk for dehydration or volume depletion;
- Evidence of hepatic disease: an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
- History of organ transplantation, cancer, liver disease;
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- Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- History of active inflammatory bowel disease within the last six months;
- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
- Pancreatic injury or pancreatitis within the last six months;
- Participation in another therapeutic trial with an investigational drug within 30 days prior to informed consent;
- 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 Children With Proteinuric Chronic Kidney Disease : a Prospective, Randomized, Placebo-controlled Trial
We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.
Read the detailed description
Blockers of renin angiotensin aldosterone system (RAAS) such as angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) are considered the standard of care in treatment of Proteinuric Chronic Kidney Disease. However, these agents lead to incomplete renal protection. The purpose of the study is to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria. In this study, participants were randomly assigned (1:1) to receive ACEI+Dapagliflozin (5mg or 10mg, based on body weight) or ACEI only once daily for 24 weeks. Prespecified outcomes includes changes in 24-hr proteinuria, albumin, eGFR (estimated glomerular filtration rate), blood pressure, body weight and so on.
- Conditions
- Proteinuria, Chronic Kidney Diseases
- Being tested
- ACEI treatment, Dapagliflozin+ACEI treatment
- Keywords
- Angiotensin Converting Enzyme Inhibitors, Sodium-glucose co-transporter 2 inhibitors, Dapagliflozin
- Medical subject headings
- Proteinuria, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACEI treatmentDrug
Also called Control group
ACEI, will be given once daily based on body weight (0.2mg/kg/d-0.6mg/kg/d，max 20mg/d), for 24 weeks
Dapagliflozin+ACEI treatmentDrug
Also called Treatment group
Dapagliflozin will be given 10 mg/day (weight>30kg) or 5mg/day (weight≤30kg), for 24 weeks ACEI, will be given based on body weight (max 20mg/d), for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ACEI treatment | Placebo comparator | Drug: ACEI will be given once daily Receives: Drug: ACEI treatment |
| Dapagliflozin+ACEI treatment | Experimental | Drug: ACEI, will be given once daily Drug: Dapagliflozin, will be given once daily Receives: Drug: Dapagliflozin+ACEI treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in 24 hour proteinuria
Urine will be collected for 24 hours and total urinary albumin excretion will be measured
Measured: From baseline to week 12
Secondary outcomes (6)
The change in 24 hour proteinuria
Urine will be collected for 24 hours and total urinary albumin excretion will be measured
Measured: From baseline to week 24
The change in albumin from baseline to week 24
Serum albumin levels are repeated measurement data
Measured: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change in eGFR (estimated glomerular filtration rate) from baseline to week 24
eGFR will be evaluated using Schwartz formula (eGFR=k*height(cm)/serum creatinine(umol/L)), k=36.5), and eGFR are repeated measurement data
Measured: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change blood pressure from baseline to week 24
Blood pressure including systolic blood pressure (SBP) and diastolic blood pressure (DBP) are repeated measurement data
Measured: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change in body weight from baseline to week 24
Body weight are repeated measurement data and will be measured in the morning
Measured: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The number of hypoglycemia episodes during the treatment
Patients will be asked to measure fasting blood glucose every morning and record the data by their parents during the treatment period. Hypoglycemia is defined as glucose level less than 3.9mmol/L.
Measured: From baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Jan 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: lack of funding
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qian Shen, Profressor, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531397
- Sponsor's protocol ID
- EASOD.01
- Status last verified
- Dec 2020
- First submitted
- 26 Aug 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease : a Prospective, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04531397
- Acronym / sponsor ID
- EASOD.01
- Conditions
- Proteinuria, Chronic Kidney Diseases
- Keywords
- Angiotensin Converting Enzyme Inhibitors, Sodium-glucose co-transporter 2 inhibitors, Dapagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Aug 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.
We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.
Detailed description
Blockers of renin angiotensin aldosterone system (RAAS) such as angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) are considered the standard of care in treatment of Proteinuric Chronic Kidney Disease. However, these agents lead to incomplete renal protection. The purpose of the study is to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria. In this study, participants were randomly assigned (1:1) to receive ACEI+Dapagliflozin (5mg or 10mg, based on body weight) or ACEI only once daily for 24 weeks. Prespecified outcomes includes changes in 24-hr proteinuria, albumin, eGFR (estimated glomerular filtration rate), blood pressure, body weight and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACEI treatment | Placebo comparator | Drug: ACEI treatmentDrug: ACEI will be given once daily |
| Dapagliflozin+ACEI treatment | Experimental | Drug: Dapagliflozin+ACEI treatmentDrug: ACEI, will be given once daily Drug: Dapagliflozin, will be given once daily |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 6 years to 18 years；
- Urinary protein excretion > 200 mg in a 24-hr urine collection；
- Without any immunosuppressant medications such as corticosteroids, CNIs and so on；
- Estimated GFR ≥ 60 ml/min/1.73m2（estimated with Schwartz formula）；
- No history of diabetes；
Key exclusion criteria (13 listed)
- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis;
- Blood pressure less than 5th percentile of the same gender, age, and height;
- Uncontrolled urinary tract infection at screening;
- At risk for dehydration or volume depletion;
- Evidence of hepatic disease: an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
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 |
|---|---|---|
| ACEI treatmentAlso: Control groupACEI, will be given once daily based on body weight (0.2mg/kg/d-0.6mg/kg/d，max 20mg/d), for 24 weeks | Drug | ACEI treatment |
| Dapagliflozin+ACEI treatmentAlso: Treatment groupDapagliflozin will be given 10 mg/day (weight>30kg) or 5mg/day (weight≤30kg), for 24 weeks ACEI, will be given based on body weight (max 20mg/d), for 24 weeks. | Drug | Dapagliflozin+ACEI treatment |
Primary outcome
The change in 24 hour proteinuria
Time frame: From baseline to week 12
Urine will be collected for 24 hours and total urinary albumin excretion will be measured
6 secondary outcomes
The change in 24 hour proteinuria
Time frame: From baseline to week 24
The change in albumin from baseline to week 24
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change in eGFR (estimated glomerular filtration rate) from baseline to week 24
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change blood pressure from baseline to week 24
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The change in body weight from baseline to week 24
Time frame: Measured at baseline, weeks 4, weeks 8, weeks 12, weeks 24
The number of hypoglycemia episodes during the treatment
Time frame: From baseline to week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Qian Shen, Profressor study director
Children's Hospital of Fudan University
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 ACEI treatment and Dapagliflozin+ACEI treatment in people with Proteinuria and Chronic Kidney Diseases, 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 7 inclusion and 13 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: withdrawn, as of the sponsor's last update on 29 Dec 2020. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 hour proteinuria (time frame: From baseline to week 12). 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 29 Dec 2020.