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OpenTrials
Completed

NCT Number: NCT05195086

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

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

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

endoxan

Drug

Immunosuppressant

Other names: Cyclophosphamide

CellCept

Drug

Immunosuppressant

Other names: Mycophenolate Mofetil

Primary outcomes

  1. clinical outcomes

    Time frame: 6 months - 12 months

    renal remission

  2. pharmacoeconomic outcomes

    Time frame: 12 months

    comparison of Direct medical costs between both regimens

  3. Quality of life outcomes

    Time frame: baseline and after 12 months

    SF36 Survey comparison between both groups

Secondary outcomes

  1. Adverse events

    Time frame: 12 months

    percentage of adverse events in each group

Sponsors and collaborators

Lead sponsor

Nada Magdy Mansour

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 18, 2022
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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