A Pharmacoeconomic Study Comparing the Use of Mycophenolate Mofetil or Cyclophosphamide as Induction Therapy in Lupus Nephritis Patients in Egypt

Sponsor
Nada Magdy Mansour (Other)
Overall Status
Completed
CT.gov ID
NCT05195086
Collaborator
(none)
122
1
35.2
3.5

Study Details

Study Description

Brief Summary

The aim of this study is to conduct a pharmacoeconomic analysis to compare the use of Mycophenolate Mofetil or i.v. Cyclophosphamide as induction therapy from a third party payer perspective in LN patients in the Egyptian context

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
122 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Pharmacoeconomic Study Comparing the Use of Mycophenolate Mofetil or Cyclophosphamide as Induction Therapy in Lupus Nephritis Patients in Egypt
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Jan 1, 2020
Actual Study Completion Date :
Jun 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Cyc group

Drug: endoxan
Immunosuppressant
Other Names:
  • Cyclophosphamide
  • MMF group

    Drug: cellcept
    Immunosuppressant
    Other Names:
  • Mycophenolate Mofetil
  • Outcome Measures

    Primary Outcome Measures

    1. clinical outcomes [6 months - 12 months]

      renal remission

    2. pharmacoeconomic outcomes [12 months]

      comparison of Direct medical costs between both regimens

    3. Quality of life outcomes [baseline and after 12 months]

      SF36 Survey comparison between both groups

    Secondary Outcome Measures

    1. Adverse events [12 months]

      percentage of adverse events in each group

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • LN patients between 18 and 65 years of age who were followed up in the Department of Rheumatology and Rehabilitation were included during the study period. All patients fulfilled at least 4 of the 11 American College of Rheumatology (ACR) revised criteria for the classification of SLE 21. Patients were included if they had active lupus nephritis LN(LN) that was confirmed by Class III, or Class IV, or Class V renal biopsy and which was performed within six months of enrolment. Furthermore, laboratory tests must show active nephritis demonstrated by a clinically significant high level of proteinuria, which might indicate a recent decline in renal function 22. Patients with class III or V LN must have either proteinuria (≥ 2 gm/day) or serum creatinine > 1.3 mg/dl. Patients with class IV must have either proteinuria ≥ 1 gm/day or serum creatinine > 1.3 mg/dl 23. Newly diagnosed patients who were given either IV CYC or oral MMF as induction therapy or patients who needed to be induced when flared up were included in the study.

    All patients signed a written informed consent form. For those below the age of 21, written informed consent was obtained from the parents.

    Exclusion Criteria:
    • Patients were excluded from the study if they had a history of known allergy to study drugs, received previous kidney transplantation, or were on continuous dialysis for more than two weeks before the study. Patients with combinations of membranous and proliferative glomerulonephritis (i.e., class III + V or class IV + V) renal biopsies were not included. Other reasons for exclusion were pregnancy and lactation, pancreatitis, current infection episode requiring IV antibiotics, severe viral infection, history of cancer, or overlapping autoimmune condition.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr El Aini Hospital Cairo Egypt 11787

    Sponsors and Collaborators

    • Nada Magdy Mansour

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nada Magdy Mansour, demonstrator at clinical pharmacy department, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05195086
    Other Study ID Numbers:
    • CP3.4.2
    First Posted:
    Jan 18, 2022
    Last Update Posted:
    Jan 18, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Keywords provided by Nada Magdy Mansour, demonstrator at clinical pharmacy department, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2022