Comparison between2 Drugs in Lupus Nephritis

NCT ID: NCT04424602

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2021-09-09

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.

Conditions

Lupus Nephritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cyclophosphamide

participants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months.

Group Type: EXPERIMENTAL

cyclo phosphamide

Intervention Type: DRUG

500mg vial

mycophenolate

participants will receive oral mycophenolat 2 to 3mg/kg for 6 months.

Group Type: ACTIVE_COMPARATOR

mycophenolate

Intervention Type: DRUG

500mg film-coated tablets.

Interventions

cyclo phosphamide

500mg vial

Intervention Type: DRUG

mycophenolate

500mg film-coated tablets.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

suzan.D.zakaria

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ALAzhar university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

0000085

Identifier Type: -

Identifier Source: org_study_id