Glomerular DiseasePhase 4NSNCT02216747
Low Dose Steroids in the Treatment of Nephrotic Syndrome Relapse
A Phase 4 study testing prednisone 60 mg/meter square Body Surface Area, prednisone 45 mg and prednisone 30 mg in people with Glomerular Disease, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well. Response to this treatment is the most important prognostic factor and this patients has a benign disease course. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Glomerular Disease
- What is being tested?
- prednisone 60 mg/meter square Body Surface Area, prednisone 45 mg and prednisone 30 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Dec 2015
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment.
Who cannot join
- Steroid resistance or treatment with Cyclosporin or Cellcept
Trial locations and contacts
1 site in 1 country.
Israel1 site
Shneider children Hospital Nephrology Institute
Petah Tikva
Amit Dagan, Doctor
About this study
Official title: Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose
Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well.
Response to this treatment is the most important prognostic factor and this patients has a benign disease course.
Read more
60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration.
guidelines for steroid dose for NS relapse are not based on retrospective clinical research but only on Nephrologists and experts opinion.
Rational- What would be the optimal low dose steroids and the shortest time of treatment in Nephrotic syndrome relapse?
Read the detailed description
Idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. The first line of therapy is prednisone and about 90% of the patients will
response to this treatment. The course of the disease is characterized of
recurrent relapses and repeated prednisone therapy. While prednisone doses and
therapy duration in the disease diagnosis has been based on multiple prospective
studies, the dose and therapy duration in the relapses was never challenged in a
prospective control study.
To address this question we designed prospective 3 arm study to evaluate the
effective of exception steroid regiment to treat relapses versus lower doses.
The study population is children in the age 2-18 year old with steroid sensitive nephrotic syndrome.
After relapse will be diagnosed based on physical exam and urine tests, the
patients will randomize to receive prednisone doses that are 60/m2 or 45/ m2 or 30/ m2.
A measurement of time to obtain remission, duration of remission est. will be collected.
We plan to recruit 100 children in this study.
- Conditions
- Glomerular Disease
- Being tested
- prednisone 60 mg/meter square Body Surface Area, prednisone 45 mg, prednisone 30 mg
- Keywords
- Idiopathic Nephrotic syndrome relapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisone 60 mg/meter square Body Surface AreaDrug
Also called Danalon
treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms
prednisone 45 mgDrug
Also called Danalon
treatment with 45 mg prednisone to compare with other arms
prednisone 30 mgDrug
Also called Danalon
treatment with 30 mg prednisone to compare with other arms.
| Study group | Role | What they receive |
|---|---|---|
| prednisone 60 mg/meter square Body Surface Aera | Active comparator | A - 60 mg Prednisone/meter square Boby Surface Area( 30 twice)/day until there are 3 days of undetected protein in urine and tapering down to 40 mg ,30 mg, 20 mg ,10 mg and 5 mg and end. Receives: Drug: prednisone 60 mg/meter square Body Surface Area |
| prednisone 45 mg/meter square BSA | Active comparator | B- 45 mg prednisone / day until there are 3 days of undetected protein in urine and then 30 mg / day for two weeks and to 30,20,10,5 mg until treatment is ended. Receives: Drug: prednisone 45 mg |
| prednisone 30 mg/meter squer BSA | Active comparator | C- treatment of twice daily prednisone 30 mg per day until there are 3 days of undetectible protein in urine and then tapering down to 20 ,10 ,5 until treatment is ended. Receives: Drug: prednisone 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nephrotic Syndrome Remission
Undetectable protein in urine for 3 days
Measured: 3 days
Secondary outcomes (1)
Remission duration
The number of weeks since the patient stopped steroids therapy and was in a complete remission.
Measured: Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glomerular DiseaseStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Dagan, Rabin Medical Center
- Investigators
- Amit Dagan, Doctor, Principal investigator, nephrology institute Shneider Children HospitalAmit Dagan, Doctor, Principal investigator, Schneider childrens Hospital Nephrology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216747
- Sponsor's protocol ID
- RMC14 6413 CTIL
- Acronym
- NS
- Status last verified
- Aug 2014
- First submitted
- 13 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hahn D, Samuel SM, Willis NS, Craig JC, Hodson EM. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD001533. doi: 10.1002/14651858.CD001533.pub7.
PubMed 39171624
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Nephrotic Syndrome Relapse With Low Steroid Dose
- ClinicalTrials.gov ID
- NCT02216747
- Acronym / sponsor ID
- NS / RMC14 6413 CTIL
- Conditions
- Glomerular Disease
- Keywords
- Idiopathic Nephrotic syndrome relapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Aug 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.
Background- Idiopathic Nephrotic syndrome is the common glomerular disease in childhood. conventional treatment is steroid treatment and nearly 90% response to this treatment well.
Response to this treatment is the most important prognostic factor and this patients has a benign disease course.
60-70% among patients that response to steroid treatment,will suffer a relapse of NS.repeated steroids courses can lead to serious adverse events in children such as low bone density,weight gain ,growth slow down ,elevated blood pressure and eye pressure.there is side effect corelation between steroid dose and treatment duration.
guidelines for steroid dose for NS relapse are not based on retrospective clinical research but only on Nephrologists and experts opinion.
Rational- What would be the optimal low dose steroids and the shortest time of treatment in Nephrotic syndrome relapse?
Detailed description
Idiopathic nephrotic syndrome in children is the most common chronic glomerular disease. The first line of therapy is prednisone and about 90% of the patients will
response to this treatment. The course of the disease is characterized of
recurrent relapses and repeated prednisone therapy. While prednisone doses and
therapy duration in the disease diagnosis has been based on multiple prospective
studies, the dose and therapy duration in the relapses was never challenged in a
prospective control study.
To address this question we designed prospective 3 arm study to evaluate the
effective of exception steroid regiment to treat relapses versus lower doses.
The study population is children in the age 2-18 year old with steroid sensitive nephrotic syndrome.
After relapse will be diagnosed based on physical exam and urine tests, the
patients will randomize to receive prednisone doses that are 60/m2 or 45/ m2 or 30/ m2.
A measurement of time to obtain remission, duration of remission est. will be collected.
We plan to recruit 100 children in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prednisone 60 mg/meter square Body Surface Aera | Active comparator | Drug: prednisone 60 mg/meter square Body Surface AreaA - 60 mg Prednisone/meter square Boby Surface Area( 30 twice)/day until there are 3 days of undetected protein in urine and tapering down to 40 mg ,30 mg, 20 mg ,10 mg and 5 mg and end. |
| prednisone 45 mg/meter square BSA | Active comparator | Drug: prednisone 45 mgB- 45 mg prednisone / day until there are 3 days of undetected protein in urine and then 30 mg / day for two weeks and to 30,20,10,5 mg until treatment is ended. |
| prednisone 30 mg/meter squer BSA | Active comparator | Drug: prednisone 30 mgC- treatment of twice daily prednisone 30 mg per day until there are 3 days of undetectible protein in urine and then tapering down to 20 ,10 ,5 until treatment is ended. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with Idiopathic nephrotic syndrome with a flair that needs steroids treatment.
Key exclusion criteria (1 listed)
- Steroid resistance or treatment with Cyclosporin or Cellcept
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 |
|---|---|---|
| prednisone 60 mg/meter square Body Surface AreaAlso: Danalontreatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms | Drug | prednisone 60 mg/meter square Body Surface Aera |
| prednisone 45 mgAlso: Danalontreatment with 45 mg prednisone to compare with other arms | Drug | prednisone 45 mg/meter square BSA |
| prednisone 30 mgAlso: Danalontreatment with 30 mg prednisone to compare with other arms. | Drug | prednisone 30 mg/meter squer BSA |
Primary outcome
Nephrotic Syndrome Remission
Time frame: 3 days
Undetectable protein in urine for 3 days
1 secondary outcome
Remission duration
Time frame: Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Derived from this study: PubMed 39171624Hahn D, Samuel SM, Willis NS, Craig JC, Hodson EM. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD001533. doi: 10.1002/14651858.CD001533.pub7.
Related trials for Glomerular Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
C3G
Not yet recruitingPhase 3
A Study to Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 4
Adjustment of Antibiotic Dosage in Pediatric Oncology Patients With Febrile Neutropenia and Augmented Renal Clearance
Febrile Neutropenia
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.
Amit Dagan, Doctor principal investigator
nephrology institute Shneider Children Hospital
Amit Dagan, Doctor principal investigator
Schneider childrens Hospital Nephrology Institute
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 prednisone 60 mg/meter square Body Surface Area, prednisone 45 mg and prednisone 30 mg in people with Glomerular Disease, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Aug 2014. 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 Israel. 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?
Results are not available in the source record.
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?
Nephrotic Syndrome Remission (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02216747, which also lists 1 linked publication.
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 15 Aug 2014.