Lupus NephritisPhase 4NCT04424602
Comparison between2 Drugs in Lupus Nephritis
A Phase 4 study testing cyclo phosphamide and mycophenolate in people with Lupus Nephritis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this work is to study the effect and side effects of the cyclophosphamide versus mycophenolate in lupus nephritis Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- cyclo phosphamide and mycophenolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2021to 9 Sep 2021
- Phase
- Phase 4
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients have systemic lupus erythromatosis with lupus nephritis either newly diagnosed or with history of SLE with lupus nephrits
- All stage of lupus nephritis except stage(i,v,vi)
- patients who accepted to participate in the study.
Who cannot join
- Patient with acute inflammatory process such as(rheumatoid arthritis or other rhumatoligical diseases).
- Patients who are taking other immunosuppressive therapy.
- Patients with malignancies.
- Patients with HCV, HBV or HIV infection.
- Patients with lupus nephritis sage(i,v,vi).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Mycophenolate andCyclophosphamide in the Treatment of Lupus Nephritis
The aim of this work is to study the effect and side effects of the cyclophosphamide versus mycophenolate in lupus nephritis
Read the detailed description
Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body.
Symptoms vary between people and may be mild to severe. common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission during which there are few symptoms.painless passage of blood or protein in the urine may often be the only presenting sign of kidney involvement.
Acute or chronic renal impairment may develop with lupus nephritis, leading to acute or end-stage kidney failure. Because of early recognition and management of SLE, end-stage renal failure occurs in less than 5% of cases; except in the black population, where the risk is many times.Nephritis is the most severe manifestation of lupus. Between 1950s and 1970s, corticosteroids were used for the treatment of lupus nephritis (LN) ,and using of cyclophosphamide(CPM), improved the outcome dramatically with 5 years survival increasing from 17% to 80%.Subsequently, intravenous (iv) CPM became the standard of care in induction regimes; however, ivCPM was associated with complications such as bladder toxicity, gonadal problems, and infections. To reduce the toxicity, low-dose of 500mg iv(CPM) every two weeks for six months showed equivalent efficacy and less side effect.
Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the rate of acute rejection following renal transplantation.
It has also been used to treat patients with other immune-mediated disorders such as immunoglobulin A nephropathy, small-vessel vasculitides and psoriasis .
Lupus nephritisis inflammation of the kidney that is caused by systemic lupus erythematous (SLE). Lupus nephritis happens when lupus involves the kidneys.its symptoms, though, are not always dramatic. for many, the first noticeable symptom is swelling of the legs, ankles and feet. less often, there can be swelling in the face or hands.
- Conditions
- Lupus Nephritis
- Being tested
- cyclo phosphamide, mycophenolate
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclo phosphamideDrug
500mg vial
mycophenolateDrug
500mg film-coated tablets.
| Study group | Role | What they receive |
|---|---|---|
| cyclophosphamide | Experimental | participants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months. Receives: Drug: cyclo phosphamide |
| mycophenolate | Active comparator | participants will receive oral mycophenolat 2 to 3mg/kg for 6 months. Receives: Drug: mycophenolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
serume creatinine (sCR)
to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range from(0.4 to1.5 mg/dl)its level increase in lupus.
Measured: 6 months
blood uerea nitrogen.
to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range ,around7to20mg/dl(2.5to7.1mmol) its level increase in lupus.
Measured: 6 months
• Erythrocyte sedimentation rate.(ESR)
can help us to determine if patients have inflammation.These investigation will be done before starting the pharmacotherapy and after the end of the therapy .its range from (15to10mm/hr)its level increase in lupus.
Measured: 6 months.
• Anti ds DNA
will done for diagnosis and ascertain activity of lupusThese investigation will be done before starting the pharmacotherapy and after the end of the therapy if the antidsDNA level are high the lupus may be active and if its level is low the lupus is less active.its rangr(<18iu/ml)
Measured: 6 months
• Complement 3 (C3)
will done for diagnosis and ascertain activity of lupus These investigation will be done before starting the pharmacotherapy and after the end of the therapy .c3range from75to175mg/lcomplementc3 level are lower in lupus.
Measured: 6 months
• complete blood count.(CBC)( red blood cells,white blood cells,platelets)
to know all information about red blood cells,white blood cells,platelets and effect of two drus on it.These investigation will be done before starting the pharmacotherapy and after the end of the therapy at six months.
Measured: 6 months
• 24h urine test for creatinine clearance and protien excretion.
the test is used to check kideny function.•These investigation will be done before starting the pharmacotherapy and after the end of the therapy.normal urinary protie-to-creatinine ratio is<0.2.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start5 Apr 2021
- Primary completion5 Sep 2021
- Study completion9 Sep 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be carried on40 patients with systemic lupus erythematous with lupus nephritis.the age group of patients will be between 20 to50 years.All lupus nephritis patients will be divided randomly into two groups. First group will be 20female patients on lupus nephritis .They will be given oral corticosteroid( 1mg/kg per day) and intra venous cyclophosphamide 500mg once every two weeks for 6months. Second group will be 20female patients on lupus nephritis they will be given oral corticosteroid(1mg/kg per day) and oral mycophenolat 2 to 3mg/kg for 6 months
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suzan.D.zakaria, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424602
- Sponsor's protocol ID
- 0000085
- Status last verified
- Jun 2022
- First submitted
- 2 May 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Mycophenolate andCyclophosphamide in the Treatment of Lupus Nephritis
- ClinicalTrials.gov ID
- NCT04424602
- Acronym / sponsor ID
- 0000085
- Conditions
- Lupus Nephritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 11 Jun 2020 (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 work is to study the effect and side effects of the cyclophosphamide versus mycophenolate in lupus nephritis
Detailed description
Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body.
Symptoms vary between people and may be mild to severe. common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission during which there are few symptoms.painless passage of blood or protein in the urine may often be the only presenting sign of kidney involvement.
Acute or chronic renal impairment may develop with lupus nephritis, leading to acute or end-stage kidney failure. Because of early recognition and management of SLE, end-stage renal failure occurs in less than 5% of cases; except in the black population, where the risk is many times.Nephritis is the most severe manifestation of lupus. Between 1950s and 1970s, corticosteroids were used for the treatment of lupus nephritis (LN) ,and using of cyclophosphamide(CPM), improved the outcome dramatically with 5 years survival increasing from 17% to 80%.Subsequently, intravenous (iv) CPM became the standard of care in induction regimes; however, ivCPM was associated with complications such as bladder toxicity, gonadal problems, and infections. To reduce the toxicity, low-dose of 500mg iv(CPM) every two weeks for six months showed equivalent efficacy and less side effect.
Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the rate of acute rejection following renal transplantation.
It has also been used to treat patients with other immune-mediated disorders such as immunoglobulin A nephropathy, small-vessel vasculitides and psoriasis .
Lupus nephritisis inflammation of the kidney that is caused by systemic lupus erythematous (SLE). Lupus nephritis happens when lupus involves the kidneys.its symptoms, though, are not always dramatic. for many, the first noticeable symptom is swelling of the legs, ankles and feet. less often, there can be swelling in the face or hands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will be carried on40 patients with systemic lupus erythematous with lupus nephritis.the age group of patients will be between 20 to50 years.All lupus nephritis patients will be divided randomly into two groups. First group will be 20female patients on lupus nephritis .They will be given oral corticosteroid( 1mg/kg per day) and intra venous cyclophosphamide 500mg once every two weeks for 6months. Second group will be 20female patients on lupus nephritis they will be given oral corticosteroid(1mg/kg per day) and oral mycophenolat 2 to 3mg/kg for 6 months
| Arm | Type | Receives |
|---|---|---|
| cyclophosphamide | Experimental | Drug: cyclo phosphamideparticipants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months. |
| mycophenolate | Active comparator | Drug: mycophenolateparticipants will receive oral mycophenolat 2 to 3mg/kg for 6 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients have systemic lupus erythromatosis with lupus nephritis either newly diagnosed or with history of SLE with lupus nephrits
- All stage of lupus nephritis except stage(i,v,vi)
- patients who accepted to participate in the study.
Key exclusion criteria (5 listed)
- Patient with acute inflammatory process such as(rheumatoid arthritis or other rhumatoligical diseases).
- Patients who are taking other immunosuppressive therapy.
- Patients with malignancies.
- Patients with HCV, HBV or HIV infection.
- Patients with lupus nephritis sage(i,v,vi).
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 |
|---|---|---|
| cyclo phosphamide500mg vial | Drug | cyclophosphamide |
| mycophenolate500mg film-coated tablets. | Drug | mycophenolate |
Primary outcome
serume creatinine (sCR)
Time frame: 6 months
to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range from(0.4 to1.5 mg/dl)its level increase in lupus.
blood uerea nitrogen.
Time frame: 6 months
to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range ,around7to20mg/dl(2.5to7.1mmol) its level increase in lupus.
• Erythrocyte sedimentation rate.(ESR)
Time frame: 6 months.
can help us to determine if patients have inflammation.These investigation will be done before starting the pharmacotherapy and after the end of the therapy .its range from (15to10mm/hr)its level increase in lupus.
• Anti ds DNA
Time frame: 6 months
will done for diagnosis and ascertain activity of lupusThese investigation will be done before starting the pharmacotherapy and after the end of the therapy if the antidsDNA level are high the lupus may be active and if its level is low the lupus is less active.its rangr(<18iu/ml)
• Complement 3 (C3)
Time frame: 6 months
will done for diagnosis and ascertain activity of lupus These investigation will be done before starting the pharmacotherapy and after the end of the therapy .c3range from75to175mg/lcomplementc3 level are lower in lupus.
• complete blood count.(CBC)( red blood cells,white blood cells,platelets)
Time frame: 6 months
to know all information about red blood cells,white blood cells,platelets and effect of two drus on it.These investigation will be done before starting the pharmacotherapy and after the end of the therapy at six months.
• 24h urine test for creatinine clearance and protien excretion.
Time frame: 6 months.
the test is used to check kideny function.•These investigation will be done before starting the pharmacotherapy and after the end of the therapy.normal urinary protie-to-creatinine ratio is<0.2.
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 21 Jun 2022.
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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?
A Phase 4 study testing cyclo phosphamide and mycophenolate in people with Lupus Nephritis, run by Al-Azhar University 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 3 inclusion and 5 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 21 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
serume creatinine (sCR) (time frame: 6 months). The study lists 7 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 21 Jun 2022.