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Trial record 63 of 146 for:    lupus AND Lupus Nephritis

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

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ClinicalTrials.gov Identifier: NCT02081183
Recruitment Status : Terminated
First Posted : March 7, 2014
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: Mycophenolate mofetil (MMF) Drug: Cyclophosphamide, Maintenance Phase Drug: Cyclophosphamide, Induction Phase Drug: Prednisone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008


Arm Intervention/treatment
Experimental: MMF, Prednisone

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.

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.
Other Name: CellCept

Drug: Cyclophosphamide, Induction Phase
0.5 - 1 g/m^2 IV pulse once per month

Drug: 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.

Active Comparator: Maintenance Cyclophosphamide, Prednisone

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.

Drug: Cyclophosphamide, Maintenance Phase
0.5-1 g/m^2 IV pulse once every 3 months

Drug: Cyclophosphamide, Induction Phase
0.5 - 1 g/m^2 IV pulse once per month

Drug: 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.




Primary Outcome Measures :
  1. Creatinine Clearance [ Time Frame: 18 months ]
    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.

  2. Urinary Protein [ Time Frame: 18 months ]
    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).

  3. Serum Creatinine [ Time Frame: 18 months ]
    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.

  4. Serum Albumin [ Time Frame: 18 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081183


Locations
Venezuela
Barquisimeto, Venezuela, 3005
Caracas, Venezuela, 1040
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02081183     History of Changes
Other Study ID Numbers: ML18989
First Posted: March 7, 2014    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Lupus Erythematosus, Systemic
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Prednisone
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents