Comparison between2 Drugs in Lupus Nephritis

Lupus Nephritis Clinical Trial

Official title:

Comparison Between Mycophenolate andCyclophosphamide in the Treatment of Lupus Nephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424602
• Other study ID #: 0000085
• Status: Completed
• Phase: Phase 4
• Start date: April 5, 2021
• Est. completion date: September 9, 2021

Study information

• Verified date: June 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this work is to study the effect and side effects of the cyclophosphamide versus mycophenolate in lupus nephritis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 9, 2021
• Est. primary completion date: September 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. All patients have systemic lupus erythromatosis with lupus nephritis either newly diagnosed or with history of SLE with lupus nephrits

2. All stage of lupus nephritis except stage(i,v,vi)

3. patients who accepted to participate in the study.

Exclusion Criteria:

1. Patient with acute inflammatory process such as(rheumatoid arthritis or other rhumatoligical diseases).

2. Patients who are taking other immunosuppressive therapy.

3. Patients with malignancies.

4. Patients with HCV, HBV or HIV infection.

5. Patients with lupus nephritis sage(i,v,vi).

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• cyclo phosphamide
500mg vial
• mycophenolate
500mg film-coated tablets.

Locations

Country	Name	City	State
Egypt	ALAzhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	6 months
Primary	• 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.	6 months.
Primary	• 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)	6 months
Primary	• 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.	6 months
Primary	• 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.	6 months
Primary	• 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.	6 months.