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

Lupus Nephritis Clinical Trial

Official title:

A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03920059
• Other study ID #: FDCC lupus
• Status: Terminated
• Phase: Phase 4
• Start date: August 20, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: January 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

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.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	Berlin Pharmaceutical Industry

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate at 48 week of therapy		48 weeks
Secondary	Adverse events		48 weeks
Secondary	Mycophenolic acid trough levels		48 weeks
Secondary	MPA-area under the curve (AUC) 0-4 hour at 12 week		12 weeks
Secondary	C3 levels		48 weeks
Secondary	Urine IP-10 levels		48 weeks
Secondary	Anti-dsDNA		48 weeks
Secondary	Relapse free survival at 96, 144 and 240 week		96, 144 and 240 weeks
Secondary	eGFR at 96, 144 and 240 week		96, 144 and 240 weeks
Secondary	Progression to CKD stage 3 or more at 96, 144 and 240 week		96, 144 and 240 weeks
Secondary	End stage renal disease at 96, 144 and 240 week		96, 144 and 240 weeks