Nephrotic Syndrome Steroid-DependentPhase 2NIL-2 piloteNCT02997150
Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study
A Phase 2 study testing IL-2 Low dose in people with Nephrotic Syndrome Steroid-Dependent and Interleukin 2, run by University Hospital, Limoges.
Trial summary
NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy via an increased production of regulatory T cells. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Nephrotic Syndrome Steroid-Dependent, Interleukin 2
- What is being tested?
- IL-2 Low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Oct 2018
- Phase
- Phase 2
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 3 and 15 years of age (included) with a steroid responsive idiopathic nephrotic syndrome
- Idiopathic nephrotic syndrome progressing for less than 1 year
- Steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are tapered off or within 3 months after their withdrawal, and reliance on steroids > 15 mg/m² every other day)
- Steroid dose at inclusion between 15 and 60 mg/m²every other day
- Patient with a stable dose of steroids within the 8 days before and after the first injection of IL2
- Patient in remission for more than 15 days
- Patient affiliated to a French health insurance
- Signed consent of parental authority
Who cannot join
- Hypersensitivity to IL2 or to one of its excipients
- Significant history or presence of cardiopathy
- Signs of evolving infection requiring an antibiotic treatment
- Respiratory distress, respiratory infection or chronic respiratory failure
- Serious dysfunction of one of the vital organs
- Leukocytes < 4000/mm3 ; platelets < 100 000/mm3; hematocrit <30%
Show all 14Show fewer
- Anomaly of serum bilirubin and creatinin levels
- History of organ allograft
- Other pre-existing autoimmune disease
- Male and female pubescent teenagers under the age of 15
- Male and female teenagers whose puberty has begun for more than one year
- Asthmatic patient
- Pregnant or breastfeeding female patient
- Participation in another therapeutic trial concurrently or 30 days prior to inclusion
About this study
NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy via an increased production of regulatory T cells.
Read the detailed description
The study will include 10 children (age: 3-15 years old). Patients will receive low doses of Interleukin 2 (0.5 million UI/m²/ injection, subcutaneously).
The treatment will be initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.
- Being tested
- IL-2 Low dose
- Keywords
- Idiopathic nephrotic syndrome-child-steroid dependant-IL2, Safety, Efficacy
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-2 Low doseDrug
Patients receive low doses of Interleukin 2: 0.5 million UI/m²/ injection subcutaneously.
The treatment is initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.
At the same time, corticoid treatment will be tapered until its complete withdrawal no later than 3 months from the first injection
| Study group | Role | What they receive |
|---|---|---|
| IL-2 low dose | Experimental | Not described Receives: Drug: IL-2 Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of success: absence of relapse of idiopathic nephrotic syndrome
Absence of relapse of idiopathic nephrotic syndrome
Measured: Day 184
Secondary outcomes (3)
Safety of Interleukin-2
Study of adverse events
Measured: Day 214
Increase of regulatory T cells after 5 injections of Interleukin-2
increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to fifth injection, expressed as a percentage
Measured: Day 8
Increase of regulatory T cells after 18 injections of Interleukin-2
increase of regulatory T cells (CD4+, CD25+, Foxp3 cells) from baseline to eighteenth injection, expressed as a percentage
Measured: Day 184
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startFeb 2017 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: no treatment available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome Steroid-DependentStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Guigonis, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997150
- Sponsor's protocol ID
- I15041 (NIL-2 pilote)
- Acronym
- NIL-2 pilote
- Status last verified
- May 2018
- First submitted
- 15 Dec 2016
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Steroid Dependent Idiopathic Nephrotic Syndrome in Children With Low Doses of Interleukin 2: a Pilot Study
- ClinicalTrials.gov ID
- NCT02997150
- Acronym / sponsor ID
- NIL-2 pilote / I15041 (NIL-2 pilote)
- Keywords
- Idiopathic nephrotic syndrome-child-steroid dependant-IL2, Safety, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no treatment available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Feb 2017 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 19 Dec 2016 (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.
NIL-2 is a clinical trial designed to evaluate the efficacy and safety of low doses of Interleukin2 in the treatment of recently diagnosed, steroid dependent idiopathic nephrotic syndrome in children. Recent data suggest that Interleukin 2 could be an effective therapy via an increased production of regulatory T cells.
Detailed description
The study will include 10 children (age: 3-15 years old). Patients will receive low doses of Interleukin 2 (0.5 million UI/m²/ injection, subcutaneously).
The treatment will be initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IL-2 low dose | Experimental | Drug: IL-2 Low dose |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children between 3 and 15 years of age (included) with a steroid responsive idiopathic nephrotic syndrome
- Idiopathic nephrotic syndrome progressing for less than 1 year
- Steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are tapered off or within 3 months after their withdrawal, and reliance on steroids > 15 mg/m² every other day)
- Steroid dose at inclusion between 15 and 60 mg/m²every other day
- Patient with a stable dose of steroids within the 8 days before and after the first injection of IL2
Key exclusion criteria (14 listed)
- Hypersensitivity to IL2 or to one of its excipients
- Significant history or presence of cardiopathy
- Signs of evolving infection requiring an antibiotic treatment
- Respiratory distress, respiratory infection or chronic respiratory failure
- Serious dysfunction of one of the vital organs
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 |
|---|---|---|
| IL-2 Low dosePatients receive low doses of Interleukin 2: 0.5 million UI/m²/ injection subcutaneously. The treatment is initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months. At the same time, corticoid treatment will be tapered until its complete withdrawal no later than 3 months from the first injection | Drug | IL-2 low dose |
Primary outcome
Number of success: absence of relapse of idiopathic nephrotic syndrome
Time frame: Day 184
Absence of relapse of idiopathic nephrotic syndrome
3 secondary outcomes
Safety of Interleukin-2
Time frame: Day 214
Increase of regulatory T cells after 5 injections of Interleukin-2
Time frame: Day 8
Increase of regulatory T cells after 18 injections of Interleukin-2
Time frame: Day 184
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 30 May 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.
Vincent Guigonis, MD principal investigator
University Hospital, Limoges
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IL-2 Low dose in people with Nephrotic Syndrome Steroid-Dependent and Interleukin 2, run by University Hospital, Limoges.
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 8 inclusion and 14 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of success: absence of relapse of idiopathic nephrotic syndrome (time frame: Day 184). 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 30 May 2018.