The purpose of this study is to define the outcome of renal function with mycophenolate mofetil (MMF) and steroid according to our protocol. Twenty four patients with the diagnosis of lupus in accordance with ACR classification criteria were enrolled.
Inclusion criteria was defined by evidence of active proliferative glomerulonephritis in the renal biopsy (WHO class IV or III lupus nephritis).
Exclusion criteria include :WHO class I or II, end stage renal disease, leukopenia, infection, history of cytotoxic drug treatment.
Study protocol:
Induction: intravenous cyclophosphamide, given as boluses once a month for 3-6 consecutive months in addition to steroid.
Maintenance: MMF (up to 2gr/day) combined with steroid.
Tapering: MMF dosage remains unchanged for the first year followed by dose reduction in the second year and then discontinuation.
Patients were followed up every month during induction therapy and every other month during the first year and every 3 months thereafter.
End points:
Criteria for:
Criteria for complete remission:
a) Complete improvement of renal and extra-renal symptoms
b) Return to within normal limits of ESR, C3, C4, Hb and fall of autoantibody titers
c) Absence of relapses and infectious complications
Criteria for partial remission:
a) No progression of renal disease
b) Regression of systemic symptoms
c) Decrease of at least 50% in dysmorphic RBC, cellular casts and proteinuria or less than 1 gr
proteinuria per day
d) Return to within normal limits of markers of inflammation
Criteria for relapse:
a) More than 50% increase in serum creatinine, dysmorphic RBC , cellular cast
b) Doubling of proteinuria
c) At least two systemic symptoms reappeared
Criteria for refractory to therapy:
No renal response in spite of 6 month treatment
Criteria for end stage renal disease:
Plasma creatinine rose and got stabilized above 5mg/dl for 3 months
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071710313N1
Registration date:2013-02-04, 1391/11/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-04, 1391/11/16
Registrant information
Name
Zahra Rezaieyazdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2753
Email address
rezaieyazdiz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2007-12-31, 1386/10/10
Expected recruitment end date
2012-12-31, 1391/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of long-term Maintenance Therapy with Mycophenolate Mofetil in Lupus Nephritis
Public title
Efficacy of Mycophenolate Mofetil on kidney involvement in Lupus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Twenty four consecutive patients with the diagnosis of lupus in accordance with ACR classification criteria were enrolled. Inclusion criteria: evidence of active proliferative glomerulonephritis in the renal biopsy (WHO class IV, III). In case of absent renal biopsy or the presence of WHO class V in biopsy, following clinical or paraclinical findings: proteinaria >1 gr/24 h (or sustained 2 to 4+ proteinuria); progressive renal failure with 30% decrease in creatinine clearance over one-year period and creatinine > 1.9 mg/dL; the presence of more than 5 red cells in HPF of urine sediment in two separate specimens taken in a year, presence of WBC, granular or hyaline casts without active infection
Exclusion criteria: WHO class I or II lupus nephritis; end stage renal disease when replacement renal therapy will be indicated, leukopenia (neutrophils < 1500/mm3) due to bone marrow suppression; recurrent episodes of bacterial infection; history of cytotoxic drug treatment for more than two weeks or pulse therapy with corticosteroids during a six-week period before study entry.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Mashhad-Iran, Tel.:(+98 511) 8412081, Fax:(+98 511)8430249, Email:ramresearch@mums.ac.ir
City
Mashhad
Postal code
Approval date
2007-12-31, 1386/10/10
Ethics committee reference number
ت2106
Health conditions studied
1
Description of health condition studied
lupus nephritis
ICD-10 code
M32.1
ICD-10 code description
Systemic lupus erythematosus with organ or system involvement
Primary outcomes
1
Description
Complete remission
Timepoint
Patients were followed up every month during induction therapy and every other month during the first year and every 3 months thereafter during 24 month maintenance therapy.
Method of measurement
a) Complete improvement of renal and extra-renal symptoms b) Return to within normal limits of ESR, C3, C4, Hb and fall of autoantibody titers c) Absence of relapses and infectious complications
Secondary outcomes
1
Description
Partial remission
Timepoint
Patients were followed up every month during induction therapy and every other month during the first year and every 3 months thereafter during 24 month maintenance therapy.
Method of measurement
a) No progression of renal disease b) Regression of systemic symptoms c) Decrease of at least 50% in dysmorphic RBC, cellular casts and proteinuria or less than 1 gr proteinuria per day d) Return to within normal limits of markers of inflammation
Intervention groups
1
Description
The treatment considered as four phases for classes III and IV of lupus nephritis:
1 ) Induction: intravenous cyclophosphamide, given as boluses once a month for 3-6 consecutive months in addition to corticosteroid.
2) Maintenance: mycophenolate mofetil (to the maximum dose of 2 gr /day) combined with corticosteroid.
3) Tapering: mycophenolate mofetil dosage remaines unchanged for the first year followed by dose reduction in the second year, in the absence of relapse or partial remission fulfilment.
4) Discontinuation : if our study goals had been achieved , the mycophenolate mofetil would have been discontinued with the further tapering of prednisolone to the lowest possible dose every day or every other day and patients' follow-up for evidence of relapse.
Those with class V lupus nephritis were given mycophenolate mofetil combined with corticosteroid since the diagnosis was made
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
zahra rezaieyazdi
Street address
mashhad- ghaem hospital- rheumatic diseases research center
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad university of medical Sciences
Full name of responsible person
Dr.Tafaghodi
Street address
Research vice chancellery, Mashhad University of Medical Sciences, Daneshgah St., Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad university of medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Rezaieyazdi
Position
Associate Professor of Rheumatology
Other areas of specialty/work
Street address
Rheumatic Diseases Research Center, Ghaem Hospital, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1801 2753
Fax
Email
rezaieyazdiz@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Rezaieyazdi
Position
Associate Professor of Rheumatology
Other areas of specialty/work
Street address
Rheumatic Diseases Research Center, Ghaem Hospital, Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 1841 0136
Fax
Email
rezaieyazdiz@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Rezaieyazdi
Position
Associated Professor of Rheumatology
Other areas of specialty/work
Street address
Rheumatic Diseases Research Center, Ghaem Hospital, Mashhad University of Medical Sciences, Iran
City
Mashhad
Postal code
Phone
+98 51 1841 0136
Fax
+98 51 1841 0138
Email
rezaieyazdiz@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)