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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMF, Prednisone | Experimental | Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m^2), intravenously (IV) pulse once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), orally (PO); the dose was reduced by 5 mg/day to a final dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received mycophenolate mofetil (MMF), 1 g/day, PO, twice daily (BID) for 2 weeks; 1.5 g/day, PO, three times daily (TID) for the next 2 weeks; 2 g/day, PO, BID for the remainder of the Maintenance Phase. Participants also received prednisone, as in the Induction Phase. |
|
| Maintenance Cyclophosphamide, Prednisone | Active Comparator | Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 - 1 g/m^2, IV, pulse once per month. Participants also received prednisone, 1 mg/kg/day), PO; the dose was reduced by 5 mg/day to a final dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, pulse once every 3 months. Participants also received prednisone, as in the Induction Phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate mofetil (MMF) | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barquisimeto | 3005 | Venezuela | ||||
Screening period include only the assessments to verified the inclusion and exclusion criteria's from ICF signature until base line visit (first dose day), no washout or run in period was expected.
Protocol Approved by National Regulatory Agency on 25 October 2005 and inclusion period ended on 21 January 2008, on three investigational sites but only two sites included patients. Sites were selected in public health care systems.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mycophenolate Mofetil (MMF), Prednisone | Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m^2), intravenously (IV) once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), tablets (or methylprednisolone IV), orally (PO); the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cyclophosphamide, Maintenance Phase | Drug | 0.5-1 g/m^2 IV pulse once every 3 months |
|
| Cyclophosphamide, Induction Phase | Drug | 0.5 - 1 g/m^2 IV pulse once per month |
|
| Prednisone | Drug | 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. |
|
| Caracas |
| 1040 |
| Venezuela |
| FG001 | Cyclophosphamide, Prednisone | Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase. |
| COMPLETED |
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| NOT COMPLETED |
|
|
No baseline analysis was performed because the study was terminated early.
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| ID | Title | Description |
|---|---|---|
| BG000 | MMF, Prednisone | Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase. |
| BG001 | Cyclophosphamide, Prednisone | Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data were not analyzed because the study was terminated early. | Posted | 18 months |
|
| ||||||||||||||||||||||
| 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). | Data were not analyzed because the study was terminated early. | Posted | 18 months |
| |||||||||||||||||||||||
| 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. | Data were not analyzed because the study was terminated early. | Posted | 18 months |
| |||||||||||||||||||||||
| 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. | Data were not analyzed because the study was terminated early. | Posted | 18 months |
|
Adverse events were reported starting with the first dose of study drug through the end of the study.
The number of participants who were included and completed the study was very limited, so the data were not sufficient to be used for a statistical analysis to have a clinical results .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MMF, Prednisone | Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase. | 0 | 5 | 0 | 5 | ||
| EG001 | Cyclophosphamide, Prednisone | Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day. Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase. | 0 | 6 | 2 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cephalea | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
|
Data were not analyzed because the study was terminated early.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D003520 | Cyclophosphamide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| >=65 years |
|
| Male |
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