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Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).
This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myfortic plus low-dose steroid | Experimental | Not necessary |
|
| Standard-dose steroid | Active Comparator | Not necessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myfortic plus low-dose steroid | Drug | Prednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off |
| Measure | Description | Time Frame |
|---|---|---|
| Complete remission (24 hour urine protein < 0.3 g) | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection | at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sydney CW Tang, MD, PhD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35230699 | Derived | Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5. | |
| 31769845 | Derived | Ma MKM, Yap DYH, Li CL, Mok MMY, Chan GCW, Kwan LPY, Lai KN, Tang SCW. Low-dose corticosteroid and mycophenolate for primary treatment of minimal change disease. QJM. 2020 Jun 1;113(6):399-403. doi: 10.1093/qjmed/hcz297. |
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| ID | Term |
|---|---|
| D009402 | Nephrosis, Lipoid |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D013256 | Steroids |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Prednisolone | Drug | 1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |