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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02081183
Other study ID # ML18989
Secondary ID
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


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
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