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Completed

NCT Number: NCT04424602

Comparison between2 Drugs in Lupus Nephritis

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

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

ALAzhar university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

cyclo phosphamide

Drug

500mg vial

Mycophenolate

Drug

500mg film-coated tablets.

Primary outcomes

  1. 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.

  2. 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.

  3. • 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.

  4. • 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)

  5. • 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.

  6. • 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.

  7. • 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Comparison Between Mycophenolate andCyclophosphamide in the Treatment of Lupus Nephritis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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