Status:
COMPLETED
A Pharmacoeconomic Study Comparing the Use of Mycophenolate Mofetil or Cyclophosphamide as Induction Therapy in Lupus Nephritis Patients in Egypt
Lead Sponsor:
Nada Magdy Mansour
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-65 years
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 pat...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 5 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05195086
Start Date
July 1 2018
End Date
June 5 2021
Last Update
January 18 2022
Active Locations (1)
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1
Kasr El Aini Hospital
Cairo, Egypt, 11787