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:
|
MMF group
|
Drug: cellcept
Immunosuppressant
Other Names:
|
Outcome Measures
Primary Outcome Measures
- clinical outcomes [6 months - 12 months]
renal remission
- pharmacoeconomic outcomes [12 months]
comparison of Direct medical costs between both regimens
- Quality of life outcomes [baseline and after 12 months]
SF36 Survey comparison between both groups
Secondary Outcome Measures
- 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: