Minimal Change DiseasePhase 3NCT06405100
Efficacy and Safety of Tacrolimus in Combination With Ripertamab in the Initial Treatment of Patients With MCD
A Phase 3 study testing Supportive care+Prednisone, Supportive care+Tacrolimus+Ripertamab and Supportive care+Ripertamab in people with Minimal Change Disease, run by Air Force Military Medical University, China.
Trial summary
To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates, lower recurrence rates, and fewer side effects in patients with MCD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Minimal Change Disease
- What is being tested?
- Supportive care+Prednisone, Supportive care+Tacrolimus+Ripertamab and Supportive care+Ripertamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Apr 2027
- Phase
- Phase 3
- 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
- Age 18-80 years old;
- Primary minimal change disease confirmed by renal biopsy (Initial therapy);
- 24h-UTP>3.5g/d or PCR>3500mg/g, and serum albumin<30g/L;
- Agree to participate in the project and sign the informed consent.
Who cannot join
- Secondary minimal change disease;
- eGFR<60 mL/min/1.73m2;
- Had history of mental disease, dysnoesia, serious cardiovascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors or other major diseases that are not suitable for clinical experiments;
- Active bleeding in the gastrointestinal tract;
- Prior treatment with corticosteroids or other immunosuppressants;
- HBV, HCV, HIV or other untreated infections, congenital or acquired immunodeficiency diseases;
Show all 12Show fewer
- Have been vaccinated with live vaccine in the past four weeks;
- Serum bilirubin > 3.6mg/dl for at least 1 month or liver function ≥3 times the upper limit of normal value;
- Allergic to prednisolone, tacrolimus, or ripertamab;
- Reluctance to use contraception or plan pregnancy/lactation within 6 months of study completion;
- Had history of alcohol/drug abuse;
- Unable to give informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Tacrolimus in Combination With Anti-CD20 Monoclonal Antibody (Ripertamab) in the Initial Treatment of Patients With Minimal Change Disease: a Multi-center Randomized Controlled Clinical Trial
To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates, lower recurrence rates, and fewer side effects in patients with MCD.
Read the detailed description
Minimal change disease is the third most common primary kidney disease in adults with idiopathic nephrotic syndrome. The pathological features of the disease are no or only slight changes under light microscope, and the foot process fusion under electron microscope. The KDIGO guidelines recommend oral adequate doses of glucocorticoids as the initial treatment for adults with MCD. However, 48%-76% of patients relapse after tapering or gradual discontinuation of the drug, requiring a high cumulative dose of glucocorticoids. As the cumulative dose of glucocorticoids increases, the potential for side effects increases. In addition, 10% to 30% of patients frequently relapse, and 15% to 30% of these are steroid dependent. Therefore, the clinical goals for patients with MCD are to achieve early remission of proteinuria, reduce hormonal side effects, and more importantly, prevent the recurrence of proteinuria.
- Conditions
- Minimal Change Disease
- Being tested
- Supportive care+Prednisone, Supportive care+Tacrolimus+Ripertamab, Supportive care+Ripertamab
- Medical subject headings
- Nephrosis, Lipoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive care+PrednisoneDrug
Also called Control group
Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.
Induction period: 1mg/kg/day. The maximum dose is not more than 60mg. The duration of adequate prednisone is a minimum of 4 weeks and a maximum of 16 weeks.
Maintenance period: A reduction of 5-10mg/wk was initiated after 2 weeks of complete remission and finally discontinued after 6 months of maintenance at 5mg/day.
Supportive care+Tacrolimus+RipertamabDrug
Also called Test group 1
Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.
Tacrolimus：Induction period: 0.05mg/kg/d. It will be given in two doses 12 hours apart. The blood concentration should be up to 5-10ng/ml. Maintenance therapy was initiated two weeks after complete remission; Maintenance period: Reduced to a blood concentration of 3-8ng/ml, and stopped after 6 months of maintenance treatment.
Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months.
Supportive care+RipertamabDrug
Also called Test group 2
Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise.
Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Supportive care+Prednisolone Receives: Drug: Supportive care+Prednisone |
| Test group 1 | Active comparator | Supportive care+Tacrolimus+Ripertamab Receives: Drug: Supportive care+Tacrolimus+Ripertamab |
| Test group 2 | Active comparator | Supportive care+Ripertamab Receives: Drug: Supportive care+Ripertamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate at 24 months
Relapse: Proteinuria>3.5g/d or PCR>3500mg/g after complete remission has been achieved.
Measured: Up to 24 months after enrollment
Secondary outcomes (5)
Relapse rate at 12/18 months
The relapse rates of MCD patients at 12 months and 18 months were observed
Measured: Up to 18 months after enrollment
Partial or complete remission at 2/6/12/24 months
Partial remission: Reduction of proteinuria to 0.3-3.5g/d, or PCR 300-3500mg/g and a decrease >50% from baseline Complete remission: Reduction of proteinuria to <0.3g/d or PCR<300mg/g
Measured: Up to 24 months after enrollment
The time from the start of treatment to achieve complete remission
The time it takes for patients with MCD to reach a state of complete remission needs to be observed
Measured: Up to 24 months after enrollment
The time from clinical complete remission to replase
Measured: Up to 24 months after enrollment
Safety-adverse events
Creatinine levels doubled from baseline; an increase ≥30% from eGFR baseline; ESRD; adverse events; drug-related adverse events, and abnormal clinical manifestations
Measured: The time from randomization until the occurrence of such adverse events, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study startMay 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Change DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Air Force Military Medical University, Shaanxi Provincial People's Hospital, Shaanxi Provincial Hospital of Chinese Medicine
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06405100
- Sponsor's protocol ID
- TAC and ripertamab in MCD
- Status last verified
- Apr 2024
- First submitted
- 4 May 2024
- Last updated
- 8 May 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tacrolimus in Combination With Anti-CD20 Monoclonal Antibody (Ripertamab) in the Initial Treatment of Patients With Minimal Change Disease: a Multi-center Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06405100
- Acronym / sponsor ID
- TAC and ripertamab in MCD
- Conditions
- Minimal Change Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Air Force Military Medical University, Shaanxi Provincial People's Hospital, Shaanxi Provincial Hospital of Chinese Medicine
- Study start
- May 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 May 2024 (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.
To evaluate the safety and efficacy of ripertamab and its combination with tacrolimus in the initial treatment of MCD to provide a treatment regimen with higher remission rates, lower recurrence rates, and fewer side effects in patients with MCD.
Detailed description
Minimal change disease is the third most common primary kidney disease in adults with idiopathic nephrotic syndrome. The pathological features of the disease are no or only slight changes under light microscope, and the foot process fusion under electron microscope. The KDIGO guidelines recommend oral adequate doses of glucocorticoids as the initial treatment for adults with MCD. However, 48%-76% of patients relapse after tapering or gradual discontinuation of the drug, requiring a high cumulative dose of glucocorticoids. As the cumulative dose of glucocorticoids increases, the potential for side effects increases. In addition, 10% to 30% of patients frequently relapse, and 15% to 30% of these are steroid dependent. Therefore, the clinical goals for patients with MCD are to achieve early remission of proteinuria, reduce hormonal side effects, and more importantly, prevent the recurrence of proteinuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Supportive care+PrednisoneSupportive care+Prednisolone |
| Test group 1 | Active comparator | Drug: Supportive care+Tacrolimus+RipertamabSupportive care+Tacrolimus+Ripertamab |
| Test group 2 | Active comparator | Drug: Supportive care+RipertamabSupportive care+Ripertamab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years old;
- Primary minimal change disease confirmed by renal biopsy (Initial therapy);
- 24h-UTP>3.5g/d or PCR>3500mg/g, and serum albumin<30g/L;
- Agree to participate in the project and sign the informed consent.
Key exclusion criteria (12 listed)
- Secondary minimal change disease;
- eGFR<60 mL/min/1.73m2;
- Had history of mental disease, dysnoesia, serious cardiovascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors or other major diseases that are not suitable for clinical experiments;
- Active bleeding in the gastrointestinal tract;
- Prior treatment with corticosteroids or other immunosuppressants;
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 |
|---|---|---|
| Supportive care+PrednisoneAlso: Control groupSupportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Induction period: 1mg/kg/day. The maximum dose is not more than 60mg. The duration of adequate prednisone is a minimum of 4 weeks and a maximum of 16 weeks. Maintenance period: A reduction of 5-10mg/wk was initiated after 2 weeks of complete remission and finally discontinued after 6 months of maintenance at 5mg/day. | Drug | Control Group |
| Supportive care+Tacrolimus+RipertamabAlso: Test group 1Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Tacrolimus：Induction period: 0.05mg/kg/d. It will be given in two doses 12 hours apart. The blood concentration should be up to 5-10ng/ml. Maintenance therapy was initiated two weeks after complete remission; Maintenance period: Reduced to a blood concentration of 3-8ng/ml, and stopped after 6 months of maintenance treatment. Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months. | Drug | Test group 1 |
| Supportive care+RipertamabAlso: Test group 2Supportive care: Control blood pressure:ACEI/ARB; Diet that is low in fat and salt; Stop smoking; Moderate exercise. Ripertamab: Given twice every two weeks at a dose of 1000mg. 1000mg is added at 6 months. | Drug | Test group 2 |
Primary outcome
Relapse rate at 24 months
Time frame: Up to 24 months after enrollment
Relapse: Proteinuria>3.5g/d or PCR>3500mg/g after complete remission has been achieved.
5 secondary outcomes
Relapse rate at 12/18 months
Time frame: Up to 18 months after enrollment
Partial or complete remission at 2/6/12/24 months
Time frame: Up to 24 months after enrollment
The time from the start of treatment to achieve complete remission
Time frame: Up to 24 months after enrollment
The time from clinical complete remission to replase
Time frame: Up to 24 months after enrollment
Safety-adverse events
Time frame: The time from randomization until the occurrence of such adverse events, up to 24 months
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 8 May 2024.
Related trials for Minimal Change Disease
Not yet recruitingPhase 2
MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
Focal Segmental Glomerulosclerosis, Glomerulonephritis Minimal Lesion
Not yet recruitingPhase 2
A Study to Evaluate the Effectiveness and Safety of Sibeprenlimab in Participants With Primary Membranous Nephropathy, Immune-mediated Focal Segmental Glomerulosclerosis, and Minimal Change Disease
Primary Membranous Nephropathy, Minimal Change Disease
Active, not recruitingPhase 1
Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
Adult Acute Myeloid Leukemia in Remission, Acute Biphenotypic Leukemia
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Supportive care+Prednisone, Supportive care+Tacrolimus+Ripertamab and Supportive care+Ripertamab in people with Minimal Change Disease, run by Air Force Military Medical University, 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 12 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: opening soon, as of the sponsor's last update on 8 May 2024. 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 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?
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 shiren Sun[Author], Doctor (18729387675, 272844142@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate at 24 months (time frame: Up to 24 months after enrollment). 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 8 May 2024.