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

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05195086
• Other study ID #: CP3.4.2
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: June 5, 2021

Study information

• Verified date: January 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 5, 2021
• Est. primary completion date: January 1, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• endoxan
Immunosuppressant
• cellcept
Immunosuppressant

Locations

Country	Name	City	State
Egypt	Kasr El Aini Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Nada Magdy Mansour

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcomes	renal remission	6 months - 12 months
Primary	pharmacoeconomic outcomes	comparison of Direct medical costs between both regimens	12 months
Primary	Quality of life outcomes	SF36 Survey comparison between both groups	baseline and after 12 months
Secondary	Adverse events	percentage of adverse events in each group	12 months