Renal InsufficiencyPhase 4Low/highIVCYNCT01861561
Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children
A Phase 4 study testing Low-dose intravenous cyclophosphamide and High-dose intravenous cyclophosphamide in people with Renal Insufficiency and Infection, run by Mahidol University at 1 site in Thailand.
Trial summary
Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous cyclophosphamide can improve renal outcomes, but considerably associated with infection. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Renal Insufficiency, Infection
- What is being tested?
- Low-dose intravenous cyclophosphamide and High-dose intravenous cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteThailand
- Study dates
- May 2013to May 2019
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child up to 15 years of age who fulfilled the 1997 updating the American College of Rheumatology revised criteria for the classification of SLE and his or her renal biopsy reveals lupus nephritis class III or IV regarding to International Society of Nephrology/Renal Pathology Society revision on the classification of the lupus nephritis.
Who cannot join
- patient who has prior renal insufficiency due to chronic kidney disease other than lupus nephritis
- patient who has the history of cyclophosphamide hypersensitivity
- patient who has prior cyclophosphamide or mycophenolate mofetil administration within 6 months
- patient who is pregnant
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Nephrology division, Department of Pediatrics, Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
Official title: Efficacy and Infectious Complications of Induction Therapy With Low-dose Versus High-dose Intravenous Cyclophosphamide for Proliferative Lupus Nephritis in Children
Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous cyclophosphamide can improve renal outcomes, but considerably associated with infection. Although severe infection is the significant complication related to poorer prognosis for juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable with obtained high-dose regimen. There was lower number of severe infection episodes, but no significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of serious infection and improve overall patient outcomes.
- Conditions
- Renal Insufficiency, Infection
- Being tested
- Low-dose intravenous cyclophosphamide, High-dose intravenous cyclophosphamide
- Medical subject headings
- Renal Insufficiency, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose intravenous cyclophosphamideDrug
Also called Cytoxan
Intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months, total 7 doses
High-dose intravenous cyclophosphamideDrug
Also called Cytoxan
Intravenous cyclophosphamide every 4 weeks/months, total in 7 doses:
the 1st dose-500 mg/m2/dose,the 2nd dose-750 mg/m2/dose, the 3rd-7th doses- 1,000 mg/m2/dose with the maximum dose at 1,500 mg/dose
| Study group | Role | What they receive |
|---|---|---|
| Low-dose intravenous cyclophosphamide | Experimental | Low-dose intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months for 7 doses. Total duration is 6 months for the induction treatment. Receives: Drug: Low-dose intravenous cyclophosphamide |
| High-dose intravenous cyclophosphamide | Active comparator | High-dose intravenous cyclophosphamide 1,000 mg/m2/dose, the first dose will be started with 500 mg/m2/dose and steped up to 750 mg/m2/dose for the second dose. Then the dosage will be increased to 1,000 mg/m2/dose for the third dose and continued the dosage through the seventh dose. Total duration is 6 months for the induction treatment. Receives: Drug: High-dose intravenous cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal response
3 main renal parameters: renal function(eCCl),proteinuria(spot urine protein/creatinine ratio, UPCR), and urine sediment (rbc,wbc,and casts) 'renal remission'
- complete- normal renal function, UPCR<0.2, and normal urine sediment(rbc<5,wbc<5/HPF,and no cast)
- partial- at least 50%improvement in 2 main parameters with UPCR <= 1.0 and without worsening of remaining main parameter
Measured: at 6 months of the treatment
Secondary outcomes (1)
infection
infectious episode classified in 3 levels
- mild infection - the infection that is not serious and the patient could be treated with oral antimicrobial agent in outpatient clinic
- moderate infection - the infection that the patient need admission or intravenous antimicrobial agent
- serious infection - the infection that the patient is critically ill and need ICU care
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2019
- Study completionMay 2019
Why it stopped: The duration of the study is longer than 5 years and we can not recruit the participants to the target number.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuntawan Piyaphanee, MD, Principal investigator, Siriraj HospitalAnirut Pattaragarn, MD, Study director, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861561
- Sponsor's protocol ID
- 125/2556(EC2)
- Acronym
- Low/highIVCY
- Status last verified
- Sep 2020
- First submitted
- 19 May 2013
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Infectious Complications of Induction Therapy With Low-dose Versus High-dose Intravenous Cyclophosphamide for Proliferative Lupus Nephritis in Children
- ClinicalTrials.gov ID
- NCT01861561
- Acronym / sponsor ID
- Low/highIVCY / 125/2556(EC2)
- Conditions
- Renal Insufficiency, Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The duration of the study is longer than 5 years and we can not recruit the participants to the target number.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 23 May 2013 (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.
Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous cyclophosphamide can improve renal outcomes, but considerably associated with infection. Although severe infection is the significant complication related to poorer prognosis for juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable with obtained high-dose regimen. There was lower number of severe infection episodes, but no significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of serious infection and improve overall patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose intravenous cyclophosphamide | Experimental | Drug: Low-dose intravenous cyclophosphamideLow-dose intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months for 7 doses. Total duration is 6 months for the induction treatment. |
| High-dose intravenous cyclophosphamide | Active comparator | Drug: High-dose intravenous cyclophosphamideHigh-dose intravenous cyclophosphamide 1,000 mg/m2/dose, the first dose will be started with 500 mg/m2/dose and steped up to 750 mg/m2/dose for the second dose. Then the dosage will be increased to 1,000 mg/m2/dose for the third dose and continued the dosage through the seventh dose. Total duration is 6 months for the induction treatment. |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child up to 15 years of age who fulfilled the 1997 updating the American College of Rheumatology revised criteria for the classification of SLE and his or her renal biopsy reveals lupus nephritis class III or IV regarding to International Society of Nephrology/Renal Pathology Society revision on the classification of the lupus nephritis.
Key exclusion criteria (4 listed)
- patient who has prior renal insufficiency due to chronic kidney disease other than lupus nephritis
- patient who has the history of cyclophosphamide hypersensitivity
- patient who has prior cyclophosphamide or mycophenolate mofetil administration within 6 months
- patient who is pregnant
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 |
|---|---|---|
| Low-dose intravenous cyclophosphamideAlso: CytoxanIntravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months, total 7 doses | Drug | Low-dose intravenous cyclophosphamide |
| High-dose intravenous cyclophosphamideAlso: CytoxanIntravenous cyclophosphamide every 4 weeks/months, total in 7 doses: the 1st dose-500 mg/m2/dose,the 2nd dose-750 mg/m2/dose, the 3rd-7th doses- 1,000 mg/m2/dose with the maximum dose at 1,500 mg/dose | Drug | High-dose intravenous cyclophosphamide |
Primary outcome
renal response
Time frame: at 6 months of the treatment
3 main renal parameters: renal function(eCCl),proteinuria(spot urine protein/creatinine ratio, UPCR), and urine sediment (rbc,wbc,and casts) 'renal remission' * complete- normal renal function, UPCR<0.2, and normal urine sediment(rbc<5,wbc<5/HPF,and no cast) * partial- at least 50%improvement in 2 main parameters with UPCR <= 1.0 and without worsening of remaining main parameter
1 secondary outcome
infection
Time frame: within 6 months
Results and safety
The study was stopped early (reason given: The duration of the study is longer than 5 years and we can not recruit the participants to the target number.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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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.
Nuntawan Piyaphanee, MD principal investigator
Siriraj Hospital
Anirut Pattaragarn, MD study director
Siriraj Hospital
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 Low-dose intravenous cyclophosphamide and High-dose intravenous cyclophosphamide in people with Renal Insufficiency and Infection, run by Mahidol University at 1 site in Thailand.
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 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: stopped early, as of the sponsor's last update on 4 Sep 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 Thailand. 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 was stopped early (reason given: The duration of the study is longer than 5 years and we can not recruit the participants to the target number.). 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?
renal response (time frame: at 6 months of the treatment). 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 4 Sep 2020.