NCT02081183

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2006

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 17, 2014

Completed
Last Updated

July 17, 2014

Status Verified

June 1, 2014

Enrollment Period

2.8 years

First QC Date

March 5, 2014

Results QC Date

June 17, 2014

Last Update Submit

June 17, 2014

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

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.

Drug: Mycophenolate mofetil (MMF)Drug: Cyclophosphamide, Induction PhaseDrug: Prednisone

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.

Drug: Cyclophosphamide, Maintenance PhaseDrug: Cyclophosphamide, Induction PhaseDrug: Prednisone

Interventions

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.

Also known as: CellCept
MMF, Prednisone
Cyclophosphamide, Maintenance PhaseDRUG

0.5-1 g/m\^2 IV pulse once every 3 months

Maintenance Cyclophosphamide, Prednisone
Cyclophosphamide, Induction PhaseDRUG

0.5 - 1 g/m\^2 IV pulse once per month

MMF, PrednisoneMaintenance Cyclophosphamide, Prednisone
PrednisoneDRUG

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.

MMF, PrednisoneMaintenance Cyclophosphamide, Prednisone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients \>=18 years of age;
  • diagnosis of systemic lupus erythematosus and lupus nephritis (class III, IV or V).

You may not qualify if:

  • patients who have received cytotoxic drugs in previous 8 weeks;
  • systemic infections;
  • hepatitis B or C, or HIV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Barquisimeto, 3005, Venezuela

Location

Unknown Facility

Caracas, 1040, Venezuela

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic AcidCyclophosphamidePrednisone

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

Data were not analyzed because the study was terminated early.

Results Point of Contact

Title
Medical Communications
Organization
Hoffman-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

March 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 17, 2014

Results First Posted

July 17, 2014

Record last verified: 2014-06

Locations

VE(2)