A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

A Study to Evaluate the Efficacy of CellCept, Administered in a Sequential Treatment Scheme, in Delaying Progressive Renal Damage in Patients With Lupus Nephritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02081183
• Other study ID #: ML18989
• Status: Terminated
• Phase: Phase 3
• First received: March 5, 2014
• Last updated: June 17, 2014
• Start date: March 2006
• Est. completion date: December 2008

Study information

• Verified date: June 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Instituto Nacional de Higiene "Rafael Rangel"
• Study type: Interventional

Clinical Trial Summary

This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)] and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. The anticipated time on study treatment is 12 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• diagnosis of systemic lupus erythematosus and lupus nephritis (class III, IV or V).

Exclusion Criteria:

• patients who have received cytotoxic drugs in previous 8 weeks;

• systemic infections;

• hepatitis B or C, or HIV.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Mycophenolate mofetil (MMF)
1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase.
• Cyclophosphamide, Maintenance Phase
0.5-1 g/m^2 IV pulse once every 3 months
• Cyclophosphamide, Induction Phase
0.5 - 1 g/m^2 IV pulse once per month
• Prednisone
1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinine Clearance	Creatinine clearance in an indicator of kidney function. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult values are 97 to 137 milliliters per minute (mL/min) for males and 88 to 128 mL/min for females.	18 months	No
Primary	Urinary Protein	Protein in urine is an indicator of kidney function. An increased urinary protein level indicates decreased kidney function. Normal values are approximately 0 to 8 milligrams per deciliter (mg/dL).	18 months	No
Primary	Serum Creatinine	Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly participants typically have smaller muscle mass.	18 months	No
Primary	Serum Albumin	Albumin is a protein made by the liver. A serum albumin test measures the amount of this protein in the clear liquid portion of the blood. Decreased serum albumin levels can be an indicator of liver and/or kidney disease, The normal range is 3.4 - 5.4 grams (g)/dL.	18 months	No