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

NCT05195086 | Completed FDA Drug

• 1 other identifier: CP3.4.2
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis, immunosuppressive agents, Mycophenolic acid, Cyclophosphamide, healthcare costs, cost saving regimen, resource-limited setting, Egypt.

Outcome Measures

Primary Outcomes (3)

• clinical outcomes

  renal remission

  6 months - 12 months

• pharmacoeconomic outcomes

  comparison of Direct medical costs between both regimens

  12 months

• Quality of life outcomes

  SF36 Survey comparison between both groups

  baseline and after 12 months

Secondary Outcomes (1)

• Adverse events

  12 months

Study Arms (2)

Cyc group

Drug: endoxan

MMF group

Drug: cellcept

Interventions

endoxan DRUG

Immunosuppressant

Also known as: Cyclophosphamide

Cyc group

cellcept DRUG

Immunosuppressant

Also known as: Mycophenolate Mofetil

MMF group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \- 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.

Sponsors & Collaborators

• Nada Magdy Mansour: lead

Study Sites (1)

Kasr El Aini Hospital

Cairo, 11787, Egypt

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Cyclophosphamide; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: demonstrator at clinical pharmacy department

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: July 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: June 5, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

EG (1)