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Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT03920059
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Berlin Pharmaceutical Industry
Information provided by (Responsible Party):
Yingyos Avihingsanon, Chulalongkorn University

Brief Summary:
A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Mycophenolate Mofetil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2027


Arm Intervention/treatment
Placebo Comparator: FD arm
MMF will be prescribed at a starting dose of 1.5 g/day and increased to 2 g/day at week 4 (if body weight ≥ 45 kg) and continue the same dose until week 24. After week 24, MMF will be lowered to 1.5 g/day.
Drug: Mycophenolate Mofetil

Description Each capsule contains Mycophenolate mofetil 250 mg. Presentation / Packing Cap 250 mg (white to off white powder, light blue/peach hard gelatin, imprinting with "MMF" on cap and "250" on body) x 10 x 10's.

Storage Store below 30 degree Celcius.


Active Comparator: CC Arm
MMF will be prescribed at a starting dose of 1.5 g/day. MPA-C0 (trough) level will be measured weekly and MMF dose will be increased by 500 mg/day every week until the MPA-C0 level ≥ 3 mg/L or the MMF dosage is 3000 mg/day. After achieving the targeted MPA-C0 level, the MMF dose adjustment will be allowed only if the MPA-C0 levels are lower than 3 mg/L for two consecutive monitoring visits. After week 12, MMF will be maintained at the same dose until week 48
Drug: Mycophenolate Mofetil

Description Each capsule contains Mycophenolate mofetil 250 mg. Presentation / Packing Cap 250 mg (white to off white powder, light blue/peach hard gelatin, imprinting with "MMF" on cap and "250" on body) x 10 x 10's.

Storage Store below 30 degree Celcius.





Primary Outcome Measures :
  1. Response rate at 48 week of therapy [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 48 weeks ]
  2. Mycophenolic acid trough levels [ Time Frame: 48 weeks ]
  3. MPA-area under the curve (AUC) 0-4 hour at 12 week [ Time Frame: 12 weeks ]
  4. C3 levels [ Time Frame: 48 weeks ]
  5. Urine IP-10 levels [ Time Frame: 48 weeks ]
  6. Anti-dsDNA [ Time Frame: 48 weeks ]
  7. Relapse free survival at 96, 144 and 240 week [ Time Frame: 96, 144 and 240 weeks ]
  8. eGFR at 96, 144 and 240 week [ Time Frame: 96, 144 and 240 weeks ]
  9. Progression to CKD stage 3 or more at 96, 144 and 240 week [ Time Frame: 96, 144 and 240 weeks ]
  10. End stage renal disease at 96, 144 and 240 week [ Time Frame: 96, 144 and 240 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 year
  • Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE
  • Active lupus nephritis (both new and flare patients can be included) defined as:

    • Within 16 weeks of randomization, had Biopsy-proven ISN class III or IV [exclude III(c), IV-S(c) and IV-G(c). Patients are permitted to have co-existing class V and
    • At screening day, has urine protein creatinine ratio (UPCR) or 24-hour urinary protein ≥ 1.0 g/g or g/day

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Child-bearing age women who refuse to use effective birth-control
  • Poor compliance
  • Estimated-GFR < 20 mL/min/1.73 m2
  • Crescentic glomeruli more than 30 percent
  • Severe extra-renal involvement of SLE
  • History of severe allergic reactions or adverse effects to MMF
  • Uncontrolled concomitant disease
  • Known active, clinically significant infection of any kind
  • History of serious recurrent or chronic infection
  • History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured)
  • Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening
  • Treatment with more than 1 g cyclophosphamide within the past 24 weeks
  • Receipt more than 3 g of IV pulse methylprednisolone within the past 12 weeks
  • Receipt prednisolone more than 30 mg/day for longer than 30 days within the past 12 weeks
  • Treatment with MMF at ≥ 1.5 g/day for over 4 weeks within the past 12 weeks
  • On treatment with Tacrolimus or Cyclosporine on the day of screening
  • Treatment with any biologic B-cell depleting therapy (e.g. anti CD-20, anti CD 22) within 52 weeks
  • Receiving concomitant medication interfering PK of MPA

    • Cholestyramine
    • Rifampin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920059


Contacts
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Contact: wonngarm kittanamongkolchai, MD 6622516704 ext 101 wonngarm.k@chulacrc.org

Locations
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Thailand
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Please Select, Thailand, 10330
Contact: wonngarm kittanamongkolchai    6622516704    wonngarm.k@chulacrc.org   
Sponsors and Collaborators
Chulalongkorn University
Berlin Pharmaceutical Industry

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Responsible Party: Yingyos Avihingsanon, Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT03920059     History of Changes
Other Study ID Numbers: FDCC lupus
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action