Lupus NephritisNCT05195086
A Pharmacoeconomic Study Comparing the Use of Mycophenolate Mofetil or Cyclophosphamide as Induction Therapy in Lupus Nephritis Patients in Egypt
An observational study of Lupus Nephritis, run by Nada Magdy Mansour at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- endoxan and cellcept
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 5 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- endoxan, cellcept
- Keywords
- Lupus Nephritis, immunosuppressive agents, Mycophenolic acid, Cyclophosphamide, healthcare costs, cost saving regimen, resource-limited setting, Egypt.
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoxanDrug
Also called Cyclophosphamide
Immunosuppressant
cellceptDrug
Also called Mycophenolate Mofetil
Immunosuppressant
| Study group | Role | What they receive |
|---|---|---|
| Cyc group | Not described Receives: Drug: endoxan | |
| MMF group | Not described Receives: Drug: cellcept |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcomes
renal remission
Measured: 6 months - 12 months
pharmacoeconomic outcomes
comparison of Direct medical costs between both regimens
Measured: 12 months
Quality of life outcomes
SF36 Survey comparison between both groups
Measured: baseline and after 12 months
Secondary outcomes (1)
Adverse events
percentage of adverse events in each group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Jul 2018
- Primary completion1 Jan 2020
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nada Magdy Mansour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nada Magdy Mansour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195086
- Sponsor's protocol ID
- CP3.4.2
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacoeconomic Study Comparing the Use of Mycophenolate Mofetil or Cyclophosphamide as Induction Therapy in Lupus Nephritis Patients in Egypt
- ClinicalTrials.gov ID
- NCT05195086
- Acronym / sponsor ID
- CP3.4.2
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, immunosuppressive agents, Mycophenolic acid, Cyclophosphamide, healthcare costs, cost saving regimen, resource-limited setting, Egypt.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Nada Magdy MansourUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyc group | – | Drug: endoxan |
| MMF group | – | Drug: cellcept |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoxanAlso: CyclophosphamideImmunosuppressant | Drug | Cyc group |
| cellceptAlso: Mycophenolate MofetilImmunosuppressant | Drug | MMF group |
Primary outcome
clinical outcomes
Time frame: 6 months - 12 months
renal remission
pharmacoeconomic outcomes
Time frame: 12 months
comparison of Direct medical costs between both regimens
Quality of life outcomes
Time frame: baseline and after 12 months
SF36 Survey comparison between both groups
1 secondary outcome
Adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
Related trials for Lupus Nephritis
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by Nada Magdy Mansour at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical outcomes (time frame: 6 months - 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.