Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949349
• Other study ID #: GBL15-001
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2016
• Last updated: March 1, 2017
• Start date: July 2015
• Est. completion date: January 25, 2017

Study information

• Verified date: March 2017
• Source: Genovate Biotechnology Co., Ltd.,
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.

Description:

This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day & 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 25, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of lupus nephritis.

• Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization.

• Stable use of low dose (=10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization.

Exclusion Criteria:

• Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis.

• Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids.

• Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks.

• Previous kidney transplant or planned transplant.

• Presence of life threatening complications such as cerebral lupus or severe infection.

• Presence of liver dysfunction.

• Presence of COPD or asthma requiring oral steroids.

• Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus.

• Presence of persistent hematuria or pyuria for causes other than lupus nephritis.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Mycophenolate mofetil
Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
• Azathioprine
Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.
• Prednisolone
Daily dose not more than 10mg, orally, for 24 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genovate Biotechnology Co., Ltd.,

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum albumin		24 weeks treatment
Primary	Change in serum creatinine		24 weeks treatment
Primary	Change in spot urine protein/creatinine ratio		24 weeks treatment
Secondary	Change in serum albumin		12 weeks treatment
Secondary	Change in serum creatinine		12 weeks treatment
Secondary	Change in spot urine protein/creatinine ratio		12 weeks treatment
Secondary	Change in cholesterol		24 weeks treatment
Secondary	Change in triglyceride		24 weeks treatment
Secondary	Change in complete blood count/differential count (CBC/DC)		24 weeks treatment
Secondary	Change in number of subjects with doubling of serum creatinine		24 weeks treatment
Secondary	Change in the average daily dose of oral prednisolone		24 weeks treatment