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

NCT03920059 | Terminated Phase 4

• 1 other identifier: FDCC lupus
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Response rate at 48 week of therapy

  48 weeks

Secondary Outcomes (10)

• Adverse events

  48 weeks

• Mycophenolic acid trough levels

  48 weeks

• MPA-area under the curve (AUC) 0-4 hour at 12 week

  12 weeks

• C3 levels

  48 weeks

• Urine IP-10 levels

  48 weeks

Study Arms (2)

FD arm

PLACEBO COMPARATOR

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

CC Arm

ACTIVE COMPARATOR

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

Interventions

Mycophenolate Mofetil DRUG

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.

CC Arm; FD arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead
• Berlin Pharmaceutical Industry: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Please Select, 10330, Thailand

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 18, 2019
• Study Start: August 20, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

TH (1)