Comparison between2 Drugs in Lupus Nephritis

Phase 4

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: mycophenolate; Drug: cyclo phosphamide

• Registration Number: NCT04424602
• Lead Sponsor: Al-Azhar University

Brief Summary

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 Timeline

• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-06-06
• Study First Posted: 2020-06-11
• Study Start: 2021-04-05
• Primary Completion: 2021-09-05
• Study Completion: 2021-09-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mycophenolate	mycophenolate	participants will receive oral mycophenolat 2 to 3mg/kg for 6 months.
cyclophosphamide	cyclo phosphamide	participants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months.

Primary Outcome Measures

Name	Time	Method
• Anti ds DNA	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)
• 24h urine test for creatinine clearance and protien excretion.	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.
serume creatinine (sCR)	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.	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.
• complete blood count.(CBC)( red blood cells,white blood cells,platelets)	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.
• Erythrocyte sedimentation rate.(ESR)	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.
• Complement 3 (C3)	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.

Trial Locations

Locations (1)

ALAzhar university; 🇪🇬 Cairo, Egypt