Idiopathic Membranous NephropathyNCT05782933
Efficacy of Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy
A study testing Rituximab and Modified Ponticelli regimen in people with Idiopathic Membranous Nephropathy, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Idiopathic membranous nephropathy (IMN) is one of the common types of primary glomerular diseases and the most common cause of nephrotic syndrome in adults. Poticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- Rituximab and Modified Ponticelli regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2022to 4 Dec 2023
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-70 years; serum albumin level <30 g/L;
- estimated glomerular filtration rate (eGFR according to the CKD-EPI formula) ≥60 mL/min per 1.73 m2;
- patients with a moderate risk of IMN and decline <50% in proteinuria despite blockade of the renin-angiotensin system 3 months before randomization;
- patients at high risk or very high risk of IMN.
Who cannot join
- secondary causes of MN;
- being pregnant or breastfeeding;
- uncontrollable active infectious disease;
- immunosuppressive treatment in the preceding 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
Zongli Diao, M.D., +861063138679, diaozl@ccmu.edu.dn
About this study
Official title: Efficacy and Safety of Low Dose Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy
Idiopathic membranous nephropathy (IMN) is one of the common types of primary glomerular diseases and the most common cause of nephrotic syndrome in adults.
Poticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. The period of glucocorticoid therapy is relatively long, and the adverse reactions caused by glucocorticoid therapy cannot be ignored. For patients who are unwilling to receive glucocorticoids and cyclophosphanide or who have treatment contraindications, cyclosporine can be used, mainly cyclosporine and tacrolimus, with the rapid overall effect but a high short-term relapse rate. In recent years, rituximab therapy has become a first-line treatment, with a high remission rate, and few side effects, but expensive. In terms of efficacy alone, the above regimen did not exceed Poticelli regimen. However, the toxic side effects of rituximab, cyclosporine may be lower than that of Poticelli regimen. Based on the preliminary experiment, this study explored a new treatment plan: low-dose rituximab combined with cyclosporine in the treatment of IMN, the efficacy is not inferior to Poticelli regimen, but the side effects are significantly reduced. The result will provide a good choice for IMN patients.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- Rituximab, Modified Ponticelli regimen
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Rituximab combined with or without cyclosporine
Modified Ponticelli regimenDrug
Corticosteroid and cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Patients received rituximab 100 and 500 mg of intravenous medication on days 1 and 2, respectively. If proteinuria was reduced from baseline by no more than 25% at 3 months, cyclosporine was administered. In addition, CD19+ B-cell count was monitored every 3 months, and another rituximab 100 and 500 mg will be administered if CD19+ B-cell count >5 cells/mL. Receives: Drug: Rituximab |
| Modified Ponticelli regimen | Active comparator | Patients received corticosteroids at months 1, 3, and 5 (methylprednisolone 0.5 g at days 1, 2, and 3, then prednisone 0.5 mg/kg/d from day-4 to day-30). At months 2, 4, and 6, patients received cyclophosphamide adjusted for age and renal function (1.0-2.0 mg/kg/day for 30 days, maximum dose 100 mg/d). Receives: Drug: Modified Ponticelli regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission of nehprotic syndrome
The primary clinical outcome was a composite outcome with complete remission or partial remission of nehprotic syndrome at 12 months. Complete remission was defined as a reduction of proteinuria to ≤ 0.3 g/24 h plus stable kidney function (eGFR ≥45 mL/min per 1.73 m2). Partial remission was defined as a reduction of proteinuria of ≥ 50% from baseline, and <3.5 g/24 h plus stable renal function (eGFR ≥45 mL/min per 1.73 m2).
Measured: 12 months
Secondary outcomes (2)
Complete remission of nehprotic syndrome
Complete remission was defined as a reduction of proteinuria to ≤ 0.3 g/24 h plus stable kidney function (eGFR ≥45 mL/min per 1.73 m2).
Measured: 12 months
adverse events
The prevalence of adverse events including infections, hyperglycemia etc will be recored.
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 posted24 Mar 2023
- Study start4 Aug 2022
- Primary completion4 Dec 2023 (estimated)
- Study completion4 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhu Liu, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782933
- Sponsor's protocol ID
- 2022-P2-250-01
- Status last verified
- Mar 2023
- First submitted
- 18 Dec 2022
- Last updated
- 24 Mar 2023
- 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 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low Dose Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT05782933
- Acronym / sponsor ID
- 2022-P2-250-01
- Conditions
- Idiopathic Membranous Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 4 Dec 2023 (estimated)
- Study completion
- 4 Dec 2023 (estimated)
- First posted
- 24 Mar 2023 (actual)
- 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.
Idiopathic membranous nephropathy (IMN) is one of the common types of primary glomerular diseases and the most common cause of nephrotic syndrome in adults.
Poticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. The period of glucocorticoid therapy is relatively long, and the adverse reactions caused by glucocorticoid therapy cannot be ignored. For patients who are unwilling to receive glucocorticoids and cyclophosphanide or who have treatment contraindications, cyclosporine can be used, mainly cyclosporine and tacrolimus, with the rapid overall effect but a high short-term relapse rate. In recent years, rituximab therapy has become a first-line treatment, with a high remission rate, and few side effects, but expensive. In terms of efficacy alone, the above regimen did not exceed Poticelli regimen. However, the toxic side effects of rituximab, cyclosporine may be lower than that of Poticelli regimen. Based on the preliminary experiment, this study explored a new treatment plan: low-dose rituximab combined with cyclosporine in the treatment of IMN, the efficacy is not inferior to Poticelli regimen, but the side effects are significantly reduced. The result will provide a good choice for IMN patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: RituximabPatients received rituximab 100 and 500 mg of intravenous medication on days 1 and 2, respectively. If proteinuria was reduced from baseline by no more than 25% at 3 months, cyclosporine was administered. In addition, CD19+ B-cell count was monitored every 3 months, and another rituximab 100 and 500 mg will be administered if CD19+ B-cell count >5 cells/mL. |
| Modified Ponticelli regimen | Active comparator | Drug: Modified Ponticelli regimenPatients received corticosteroids at months 1, 3, and 5 (methylprednisolone 0.5 g at days 1, 2, and 3, then prednisone 0.5 mg/kg/d from day-4 to day-30). At months 2, 4, and 6, patients received cyclophosphamide adjusted for age and renal function (1.0-2.0 mg/kg/day for 30 days, maximum dose 100 mg/d). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-70 years; serum albumin level <30 g/L;
- estimated glomerular filtration rate (eGFR according to the CKD-EPI formula) ≥60 mL/min per 1.73 m2;
- patients with a moderate risk of IMN and decline <50% in proteinuria despite blockade of the renin-angiotensin system 3 months before randomization;
- patients at high risk or very high risk of IMN.
Key exclusion criteria (4 listed)
- secondary causes of MN;
- being pregnant or breastfeeding;
- uncontrollable active infectious disease;
- immunosuppressive treatment in the preceding 3 months.
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 |
|---|---|---|
| RituximabRituximab combined with or without cyclosporine | Drug | Rituximab |
| Modified Ponticelli regimenCorticosteroid and cyclophosphamide | Drug | Modified Ponticelli regimen |
Primary outcome
remission of nehprotic syndrome
Time frame: 12 months
The primary clinical outcome was a composite outcome with complete remission or partial remission of nehprotic syndrome at 12 months. Complete remission was defined as a reduction of proteinuria to ≤ 0.3 g/24 h plus stable kidney function (eGFR ≥45 mL/min per 1.73 m2). Partial remission was defined as a reduction of proteinuria of ≥ 50% from baseline, and <3.5 g/24 h plus stable renal function (eGFR ≥45 mL/min per 1.73 m2).
2 secondary outcomes
Complete remission of nehprotic syndrome
Time frame: 12 months
adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
Beijing Friendship Hospital, Capital Medical University
Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab and Modified Ponticelli regimen in people with Idiopathic Membranous Nephropathy, run by Beijing Friendship Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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 China. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
remission of nehprotic syndrome (time frame: 12 months). 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 24 Mar 2023.