Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis

Lupus Nephritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042457
• Other study ID #: 2009-002
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2010
• Last updated: September 27, 2013
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic acid levels at 1-hour post dose will be monitored monthly up to 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 16-60 years.

• Ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements

• Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening

• Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (>90% chronic irreversible scarring)

Exclusion Criteria:

Relates to SLE

• Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR < 30 ml/min(except creatinine clearance or MDRD-GFR > 50 ml/min in the 12 weeks prior to screening)

• History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.

Related to Treatment

• Previous of any Mycophenolate groups in the 3 months prior to screening.

• Treatment with more than 2 g Cyclophosphamide in the last 6 months period prior to screening.

• Receipt of more than 3 g IV pulse methylprednisolone within the last 3 months prior to screening.

• Receipt of prednisolone dose > 30 mg/day for longer than 30 days within last 3 months prior to screening.

Related to General Health

• Pregnancy or breast feeding mothers.

• Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.

• History of cancer, including solid tumors, hematological malignancies and carcinoma.

• History of serious recurrent or chronic infection.

• Evidence of current abuse of drugs or alcohol.

Related to Laboratory Findings

• Neutrophile < 1,500/mm3, Hb < 7g/L, Platelet < 50,000/mm3 (except active SLE)

• Positive HBsAg or anti-HCV or anti-HIV.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Mycophenolate mofetil
Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month		24 weeks	Yes
Secondary	To determine Mycophenolic acid level related side effect.		24 weeks	Yes

External Links

•   (Lupus Research Unit)