Comparison between2 Drugs in Lupus Nephritis

NCT04424602 | Completed Phase 4

• 1 other identifier: 0000085
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• • 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.

• • 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

• • 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

• • 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

• • 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.

Study Arms (2)

cyclophosphamide

EXPERIMENTAL

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

Drug: cyclo phosphamide

mycophenolate

ACTIVE COMPARATOR

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

Drug: mycophenolate

Interventions

cyclo phosphamide DRUG

500mg vial

cyclophosphamide

mycophenolate DRUG

500mg film-coated tablets.

mycophenolate

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

ALAzhar university

Cairo, Egypt

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: June 11, 2020
• Study Start: April 5, 2021
• Primary Completion: September 5, 2021
• Study Completion: September 9, 2021
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

EG (1)