Lupus NephritisPhase 3CONTROLNCT01015456
The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
A Phase 3 study testing mycophenolate sodium and cyclophosphamide in people with Lupus Nephritis, run by Chulalongkorn University at 3 sites in Thailand.
Trial summary
To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- mycophenolate sodium and cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesThailand
- Study dates
- Jan 2010to Jan 2013
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 16 years of above at the time of screening
- ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements
- Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening
- Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (>90% chronic irreversible scarring)
- Relapse or resistant to (3 consecutive doses) IVCY
- Resistant lupus or Relapse lupus nephritis defined as follows:
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- Increase in serum creatinine >/= 0.3 mg/dl or
- Increase in proteinuria > 1.5 g/day (which must have improved by ≥ 50% in the preceding 3 months)
- Life-time cumulative dose of IVCY > 6 grams
- Female patients of childbearing potential must have a negative serum pregnancy
Who cannot join
- Relates to SLE
- Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli ≥ 30%
- Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR < 30 ml/min(except creatinine clearance or MDRD-GFR > 50 ml/min in the 12 weeks prior to screening)
- History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.
- Severe extra-renal organ involvement
- Related to Treatment
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- Previous of any Mycophenolate groups in the 6 months prior to screening
- Treatment with any investigational drugs in the 3 months prior to screening
- Related to General Health
- Pregnancy or breast feeding mothers.
- Concomitant condition which has required treatment moderate to high dose steroid in the 12 weeks prior to screening.
- Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
- History of cancer, including solid tumors, hematological malignancies and carcinoma.
- Evidence of current abuse of drugs or alcohol.
- Related to Laboratory Findings
- Neutrophile < 1,500/mm3, Hb < 7g/L, Platelet < 50,000/mm3 (except active SLE)
- Positive HBsAg or anti-HCV or anti-HIV.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Nopparat Rajathani
Bangkok
Khon Kaen University
Khon Kaen, Changwat Khon Kaen
Thammasart University
Pathum Thani
About this study
Official title: The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis
To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.
Read the detailed description
In this study, there are two sub-studies in order to define secondary endpoints.
- Pharmacokinetics study of Mycophenolic acid
- Identify biomarkers for therapy-resistant prediction.
- Identify biomarkers for predicting a loss of kidney function.
- Conditions
- Lupus Nephritis
- Being tested
- mycophenolate sodium, cyclophosphamide
- Keywords
- lupus nephritis, mycophenolate sodium, cyclophosphamide
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycophenolate sodiumDrug
Also called Myfortic
per oral, twice daily, for 12 months
cyclophosphamideDrug
Also called Cytoxan
intravenous, monthly, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral mycophenolate sodium 1440 mg per day for 12 months Receives: Drug: mycophenolate sodium |
| 2 | Active comparator | Intravenous cyclophosphamide monthly for 6 months Receives: Drug: cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis
Measured: 12 months
Secondary outcomes (3)
The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment
Measured: 12 months
The ratio of patients with declined renal function
Measured: 12 months
Time to remission
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Data Safety Monitoring Board concerning of the participants' safety
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 Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Collaborative Network, Health Intervention and Technology Assessment Program (HITAP)
- Responsible party
- Principal investigator, Yingyos Avihingsanon, Chulalongkorn University
- Investigators
- Yingyos Avihingsanon, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015456
- Sponsor's protocol ID
- 2009-001
- Other IDs
- Lupus Research Unit, CRCN, HITAP
- Acronym
- CONTROL
- Status last verified
- Oct 2014
- First submitted
- 17 Nov 2009
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Anutrakulchai S, Panaput T, Wongchinsri J, Chaishayanon S, Satirapoj B, Traitanon O, Pima W, Rukrung C, Thinkhamrop B, Avihingsanon Y. A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience. Lupus Sci Med. 2016 Jan 14;3(1):e000120. doi: 10.1136/lupus-2015-000120. eCollection 2016.
PubMed 26835147
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis
- ClinicalTrials.gov ID
- NCT01015456
- Acronym / sponsor ID
- CONTROL / 2009-001
- Conditions
- Lupus Nephritis
- Keywords
- lupus nephritis, mycophenolate sodium, cyclophosphamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data Safety Monitoring Board concerning of the participants' safety
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Clinical Research Collaborative Network, Health Intervention and Technology Assessment Program (HITAP)
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 18 Nov 2009 (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.
To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.
Detailed description
In this study, there are two sub-studies in order to define secondary endpoints.
- Pharmacokinetics study of Mycophenolic acid
- Identify biomarkers for therapy-resistant prediction.
- Identify biomarkers for predicting a loss of kidney function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mycophenolate sodiumOral mycophenolate sodium 1440 mg per day for 12 months |
| 2 | Active comparator | Drug: cyclophosphamideIntravenous cyclophosphamide monthly for 6 months |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- age 16 years of above at the time of screening
- ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements
- Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening
- Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (>90% chronic irreversible scarring)
- Relapse or resistant to (3 consecutive doses) IVCY
Key exclusion criteria (17 listed)
- Relates to SLE
- Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli ≥ 30%
- Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR < 30 ml/min(except creatinine clearance or MDRD-GFR > 50 ml/min in the 12 weeks prior to screening)
- History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.
- Severe extra-renal organ involvement
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 |
|---|---|---|
| mycophenolate sodiumAlso: Myforticper oral, twice daily, for 12 months | Drug | 1 |
| cyclophosphamideAlso: Cytoxanintravenous, monthly, for 6 months | Drug | 2 |
Primary outcome
Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis
Time frame: 12 months
3 secondary outcomes
The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment
Time frame: 12 months
The ratio of patients with declined renal function
Time frame: 12 months
Time to remission
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Data Safety Monitoring Board concerning of the participants' safety). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Derived from this study: PubMed 26835147Anutrakulchai S, Panaput T, Wongchinsri J, Chaishayanon S, Satirapoj B, Traitanon O, Pima W, Rukrung C, Thinkhamrop B, Avihingsanon Y. A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience. Lupus Sci Med. 2016 Jan 14;3(1):e000120. doi: 10.1136/lupus-2015-000120. eCollection 2016.
- Lupus Research UnitLink provided by the sponsor.
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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.
Yingyos Avihingsanon, MD principal investigator
Chulalongkorn University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mycophenolate sodium and cyclophosphamide in people with Lupus Nephritis, run by Chulalongkorn University at 3 sites 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 10 inclusion and 17 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 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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 was stopped early (reason given: Data Safety Monitoring Board concerning of the participants' safety). 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?
Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis (time frame: 12 months). 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 NCT01015456, 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 10 Oct 2014.