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Cyclophosphamide Versus Mycophenolate Mofetil in Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03200002
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : June 28, 2017
Information provided by (Responsible Party):
Arun Sedhain, Chitwan Medical College

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.

Condition or disease Intervention/treatment Phase
To Compare the Effects of Mycophenolate Mofetil With Cyclophosphamide in Neplaese Lupus Nephritis Patients Drug: Cyclophosphamide Drug: Mycophenolate Mofetil Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Cyclophosphamide Versus Mycophenolate Mofetil in Induction Therapy of Lupus Nephritis in Nepalese Population
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : June 30, 2015

Arm Intervention/treatment
Experimental: Cyclophosphamide
Participants in this arm received intravenous cyclophosphamide (CYC) in the dose of 0.5 to 1 gram per m2 of body surface area.
Drug: Cyclophosphamide
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.

Experimental: mycophenolate mofetil
Patients in this arm received mycophenolate mofetil in the tablet form.
Drug: Mycophenolate Mofetil
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.

Primary Outcome Measures :
  1. partial remission [ Time Frame: 6 months ]
    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

Secondary Outcome Measures :
  1. Complete remission [ Time Frame: 6 months ]
    normalization of serum creatinine and < 500 mg of 24 hour urinary protein

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 68 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Newly diagnosed LN with ISN/RPS histopathology classes III to V

Exclusion Criteria:

  • 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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Arun Sedhain, Associate Professor, Chitwan Medical College Identifier: NCT03200002     History of Changes
Other Study ID Numbers: LN_CYC_MMF
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Arun Sedhain, Chitwan Medical College:
Lupus Nephritis, cyclophosphamide, Mycophenolate mofetil
Additional relevant MeSH terms:
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Mycophenolic Acid
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors