Lupus NephritisNCT02954939
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
A study testing MMF-MMF and CTX-AZA in people with Lupus Nephritis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- MMF-MMF and CTX-AZA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2017to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with biopsy proven Class III/IV+/-V LN (ISN/RPS classification) and active nephritis as indicated by an increase of proteinuria >1g/day and/or rise in serum creatinine by >15% compared with baseline, with or without serological reactivation.
- 2. Willing to give informed consent
Who cannot join
- Patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months
- Patients have received biologics therapy (e.g. rituximab, abatacept) in the preceding 12 months
- Patients who are pregnant or lactating
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Desmond Yap, MD (HK), 85222554385, desmondy@hku.hk
About this study
Official title: The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets and Relationship With Relapse
This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.
Read the detailed description
This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.
- Conditions
- Lupus Nephritis
- Being tested
- MMF-MMF, CTX-AZA
- Keywords
- lupus nephritis, lymphocyte subsets, cytokines, mycophenolate mofetil, 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.
MMF-MMFDrug
Also called PRED; MMF
Class III/IV+/-V lupus nephritis patients to receive PRED+MMF
CTX-AZADrug
Also called PRED; CTX; AZA
Class III/IV+/-V lupus nephritis patients to receive PRED+CTX followed by AZA
| Study group | Role | What they receive |
|---|---|---|
| MMF-MMF | Active comparator | Class III/IV+V LN patients who receive prednisolone (PRED) (0.8mg/kg/d) plus mycophenolate mofetil (MMF) (1g bd) as induction-maintenance therapy Receives: Drug: MMF-MMF |
| CTX-AZA | Placebo comparator | Class III/IV+V LN patients who receive prednisolone (PRED) (0.8mg/kg/d) plus Cyclophosphamide (CTX) (1.5-2mg/kg/d) followed by Azathioprine (AZA) (1-1.5mg/kg/d) as induction-maintenance therapy Receives: Drug: CTX-AZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte subset profile (CD8+ T cells, CD4+ Th1, Th2, Th17 & Treg), Naïve & memory B cells, plasma cells
Measured: 48 weeks
Secondary outcomes (1)
serum cytokine profile (IL-2, IL-5, IL-6, IL-7, IL-10, IL-17, IL-21, IL-23, IFN-alpha, IFN-gamma, TGF-beta)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start1 Mar 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954939
- Sponsor's protocol ID
- UW12-389
- Status last verified
- Dec 2024
- First submitted
- 13 Sep 2016
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets and Relationship With Relapse
- ClinicalTrials.gov ID
- NCT02954939
- Acronym / sponsor ID
- UW12-389
- Conditions
- Lupus Nephritis
- Keywords
- lupus nephritis, lymphocyte subsets, cytokines, mycophenolate mofetil, cyclophosphamide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Nov 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.
This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.
Detailed description
This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMF-MMF | Active comparator | Drug: MMF-MMFClass III/IV+V LN patients who receive prednisolone (PRED) (0.8mg/kg/d) plus mycophenolate mofetil (MMF) (1g bd) as induction-maintenance therapy |
| CTX-AZA | Placebo comparator | Drug: CTX-AZAClass III/IV+V LN patients who receive prednisolone (PRED) (0.8mg/kg/d) plus Cyclophosphamide (CTX) (1.5-2mg/kg/d) followed by Azathioprine (AZA) (1-1.5mg/kg/d) as induction-maintenance therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients with biopsy proven Class III/IV+/-V LN (ISN/RPS classification) and active nephritis as indicated by an increase of proteinuria >1g/day and/or rise in serum creatinine by >15% compared with baseline, with or without serological reactivation.
- 2. Willing to give informed consent
Key exclusion criteria (3 listed)
- Patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months
- Patients have received biologics therapy (e.g. rituximab, abatacept) in the preceding 12 months
- Patients who are pregnant or lactating
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 |
|---|---|---|
| MMF-MMFAlso: PRED; MMFClass III/IV+/-V lupus nephritis patients to receive PRED+MMF | Drug | MMF-MMF |
| CTX-AZAAlso: PRED; CTX; AZAClass III/IV+/-V lupus nephritis patients to receive PRED+CTX followed by AZA | Drug | CTX-AZA |
Primary outcome
Lymphocyte subset profile (CD8+ T cells, CD4+ Th1, Th2, Th17 & Treg), Naïve & memory B cells, plasma cells
Time frame: 48 weeks
1 secondary outcome
serum cytokine profile (IL-2, IL-5, IL-6, IL-7, IL-10, IL-17, IL-21, IL-23, IFN-alpha, IFN-gamma, TGF-beta)
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMF-MMF and CTX-AZA in people with Lupus Nephritis, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 16 Dec 2024. 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 Hong Kong. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desmond YAP, MD (HK) (22554385, desmondy@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocyte subset profile (CD8+ T cells, CD4+ Th1, Th2, Th17 & Treg), Naïve & memory B cells, plasma cells (time frame: 48 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 16 Dec 2024.