Cyclophosphamide Versus Mycophenolate Mofetil in Lupus Nephritis
Effect of Cyclophosphamide Versus Mycophenolate Mofetil in Induction Therapy of Lupus Nephritis in Nepalese Population
1 other identifier
interventional
49
0 countries
N/A
Brief Summary
This was a prospective open label randomized control trial, which was conducted for a period of one and half year from January 2014 to June 2015. Out of 52 patients screened, 49 patients meeting the international society of nephrology/ renal pathology society (ISN/RPS) criteria were enrolled in the study comprising of 25 and 24 patients in the cyclophosphamide (CYC) and mycophenolate mofetil (MMF) groups respectively. Forty two patients (21 in each group) could complete the study till the end of 6 months and were included in final analysis. Baseline clinical evaluation and investigations were done and recorded. CYC was given intravenously as a monthly pulse in the dose of 0.5 to 1 gram per m2 body surface area. MMF was administered in the tablet form with the starting dose of 500 mg twice daily, which was increased to 750 mg twice daily after a month. Patients were assessed and monitored monthly and the details were recorded. Efficacy of treatment was measured as primary end point for those who achieved partial remission (reduction of 24 hour urinary protein to \< 3.5gms/day if baseline proteinuria \>3.5 gms/day or decrease by 50% if baseline proteinuria \<3.5 gms/day) and secondary end point for those who achieved complete remission (normalization of serum creatinine and \< 500 mg of 24 hour urinary protein). Adverse events experienced by the patients were also recorded during monthly visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2014
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2015
CompletedFirst Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedJune 28, 2017
June 1, 2017
1.5 years
June 20, 2017
June 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
partial remission
reduction of 24 hour urinary protein to \< 3.5gms/day if baseline proteinuria \>3.5 gms/day or decrease by 50% if baseline proteinuria \<3.5 gms/day
6 months
Secondary Outcomes (1)
Complete remission
6 months
Study Arms (2)
Cyclophosphamide
EXPERIMENTALParticipants in this arm received intravenous cyclophosphamide (CYC) in the dose of 0.5 to 1 gram per m2 of body surface area.
mycophenolate mofetil
EXPERIMENTALPatients in this arm received mycophenolate mofetil in the tablet form.
Interventions
Cyclophosphamide injection was administered in the dose of 0.5 to 1 gram per m2 of body surface area. The medicine, which is available in the strength of 1 gram in powder form, was first dissolved in 20 ml of normal saline. Only15 ml of this preparation was mixed in 100 ml of normal saline and was infused over a period of one hour. CYC was not given to those patients who had total leukocyte counts (TLC) less than 2500/mm3. Those patients were re-evaluated after one week and intravenous pulse CYC was reinstituted if the TLC exceeds 2500/mm3. Pulse CYC was administered every month for a total of six infusions.
Participants in the MMF group were administered tablet mycophenolate mofetil at a starting dose of 500 mg twice daily if the weight of the patient was less than 50 kilograms and 750 mg twice daily if the weight was more than 50 kilograms. After one month, the dose of MMF was increased to 750 mg twice daily. The clinical response was monitored in terms of reduction in serum creatinine and proteinuria. MMF dose was decreased or interrupted in patients experiencing an absolute neutrophil count \<1300/mm3 at any study visit; MMF treatment was discontinued if a patient experienced an absolute neutrophil count \<1000/mm3.
Eligibility Criteria
You may qualify if:
- Newly diagnosed LN with ISN/RPS histopathology classes III to V
You may not qualify if:
- Patients with biopsy had proven ISN / RPS classes I, II and VI LN
- Patients with previous history of treatment and relapse of lupus nephritis
- Patients who were receiving continuous dialysis for more than two weeks prior to randomization.
- Patients of less than 12 years of age
- Patients who had concurrent infection or illness at the time of enrollment
- Patients who were taking concurrent medications which are supposed to have interactions with MMF or CYC
- Female patients who were pregnant and breastfeeding.
- Patients who did not give consent for participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Sedhain A, Hada R, Agrawal RK, Bhattarai GR, Baral A. Low dose mycophenolate mofetil versus cyclophosphamide in the induction therapy of lupus nephritis in Nepalese population: a randomized control trial. BMC Nephrol. 2018 Jul 11;19(1):175. doi: 10.1186/s12882-018-0973-7.
PMID: 29996800DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 27, 2017
Study Start
January 1, 2014
Primary Completion
June 30, 2015
Study Completion
June 30, 2015
Last Updated
June 28, 2017
Record last verified: 2017-06