ProteinuriaPhase 3NCT02232763
Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
A Phase 3 study testing Losartan in people with Proteinuria, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria. Read more about this study
- Who is it for?
- Ages 24 months to 18 years
- Conditions the study is for
- Proteinuria
- What is being tested?
- Losartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Sep 2016
- Phase
- Phase 3
- 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 24 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 2years or older and younger than 18 years
- estimated GFR ≥ 30mL/min/m^2
- Mean urinary protein-creatinine ratio > 0.3 g/g from three first-morning spot urine collections
- Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)
Who cannot join
- hypertension
- under dialysis or organ transplanted
- bilateral renal artery stenosis or primary hyperaldosteronism
- pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Cross-over Study Evaluating the Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.
Read the detailed description
Children with tubular proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed over to the opposite intervention for another three months after a washout period of 2 weeks. The primary outcome is the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also investigated with additional retrospective review of medical record.
- Conditions
- Proteinuria
- Being tested
- Losartan, Placebo
- Keywords
- Losartan, children, proteinuria
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
12 weeks of losartan or placebo with crossover to the other
PlaceboDrug
12 weeks of losartan or placebo with crossover to the other
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | 12 weeks of losartan or placebo with crossover to the other Receives: Drug: Losartan |
| Placebo | Experimental | 12 weeks of losartan or placebo with crossover to the other Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (4)
the change in urinary albumin-creatinine ratio from baseline to the end of study
Change in urinary albumin excretion, determined as urinary albumin-creatinine ratio compared to baseline, after 12 weeks of treatment
Measured: 12 weeks
the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio
number of patients with wifh more than 50% decrease of urinary protein-creatinine ratio compared to baseline, after 12 weeks of treatment
Measured: 12 weeks
the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study
Change in urinary beta2-microglobulin--creatinine ratio compared to baseline, after 12 weeks of treatment
Measured: 12 weeks
the change in urinary NAG-creatinine ratio from baseline to the end of study
Change in urinary NAG-creatinine ratio compared to baseline, after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionSep 2016
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 Seoul National University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Responsible party
- Sponsor
- Investigators
- Hee Gyung Kang, Ph.D, Study chair, Seoul National University Children's Hospital Departments of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232763
- Sponsor's protocol ID
- Losartan_tubularPU_2014
- Status last verified
- Jul 2017
- First submitted
- 3 Sep 2014
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Cross-over Study Evaluating the Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
- ClinicalTrials.gov ID
- NCT02232763
- Acronym / sponsor ID
- Losartan_tubularPU_2014
- Conditions
- Proteinuria
- Keywords
- Losartan, children, proteinuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Study start
- Sep 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Sep 2014 (estimated)
- 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 investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.
Detailed description
Children with tubular proteinuria (urine protein to creatinine ratio > 0.3 mg/mg) were randomly assigned in 1:1 ratio to losartan or placebo treatment for 12 weeks, then crossed over to the opposite intervention for another three months after a washout period of 2 weeks. The primary outcome is the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks. Efficacy of losartan in children with CKD with tubular proteinuria was also investigated with additional retrospective review of medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: Losartan12 weeks of losartan or placebo with crossover to the other |
| Placebo | Experimental | Drug: Placebo12 weeks of losartan or placebo with crossover to the other |
Who may qualify
- Ages
- 24 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 2years or older and younger than 18 years
- estimated GFR ≥ 30mL/min/m^2
- Mean urinary protein-creatinine ratio > 0.3 g/g from three first-morning spot urine collections
- Renal hypoplasia/dysplasia, Reflux nephropathy, Polycystic kidney disease, Lowe syndrome, Dent disease, Tubulointerstitial nephritis, Nephronophthisis/Medullary cystic disease, Obstructive uropathy(including PUV, UPJ obstruction, UVJ obstruction)
Key exclusion criteria (4 listed)
- hypertension
- under dialysis or organ transplanted
- bilateral renal artery stenosis or primary hyperaldosteronism
- pregnant or nursing
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 |
|---|---|---|
| LosartanAlso: Cozaar12 weeks of losartan or placebo with crossover to the other | Drug | Losartan |
| Placebo12 weeks of losartan or placebo with crossover to the other | Drug | Placebo |
Primary outcome
the change in urinary protein-creatinine ratio from baseline to the end of 12 weeks
Time frame: 12 weeks
Change in urinary protein excretion, determined as urinary Protein-creatinine ratio compared to baseline, after 12 weeks of treatment
4 secondary outcomes
the change in urinary albumin-creatinine ratio from baseline to the end of study
Time frame: 12 weeks
the proportion of patients wifh more than 50% decrease of urinary protein-creatinine ratio
Time frame: 12 weeks
the change in urinary beta2-microglobulin-creatinine ratio from baseline to the end of study
Time frame: 12 weeks
the change in urinary NAG-creatinine ratio from baseline to the end of study
Time frame: 12 weeks
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 10 Oct 2018.
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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.
Hee Gyung Kang, Ph.D study chair
Seoul National University Children's Hospital Departments of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Losartan in people with Proteinuria, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 4 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 10 Oct 2018. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 urinary protein-creatinine ratio from baseline to the end of 12 weeks (time frame: 12 weeks). 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 10 Oct 2018.