A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.

Glomerulonephritis, IGA Clinical Trial

Official title:

Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02160132
• Other study ID #: Usix-IgAN-001
• Status: Recruiting
• Phase: Phase 2
• First received: June 3, 2014
• Last updated: March 2, 2015
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Sun Yat-sen University
• Contact: Zongpei Jiang, M.D. & Ph.D.
• Phone: 8620-38379727
• Email: jx.home[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.

Description:

It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR＞50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days,with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. Furthermore, as we know, active pathological changes in IgAN,including crescents,necrosis and microthrombus,which may turn fibrosis after three months would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 14~65 years, regardless of gender

• Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus.

• Average urinary protein excretion of 0.5~3.5g/24h on two successive examinations.

• eGFR = 50 ml/min/1.73 m2

• Willingness to sign an informed consent.

Exclusion Criteria:

• Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.

• Rapidly progressive nephritic syndrome (crescent formation=50%).

• Acute renal failure, including rapidly progressive IgAN.

• Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX?MMF?CsA?FK506).

• Date of renal biopsy exceeds more than 30 days.

• Cirrhosis, chronic active liver disease.

• History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).

• Any Active systemic infection or history of serious infection within one month.

• Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases).

• Active tuberculosis

• Malignant hypertension that is difficult to be controlled by oral drugs.

• Known allergy, contraindication or intolerance to the steroids.

• Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.

• Malignant tumors

• Excessive drinking or drug abuse

• Mental aberrations

• Current or recent (within 30 days) exposure to any other investigational drugs.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA
• Kidney Diseases
• Necrosis
• Peripapillary Crescent
• Steroid Nephropathy

Intervention

Drug:
• Methylprednisolone(intravenously in the 1st-2nd-3rd month )
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
• Methylprednisolone(intravenously in the 1st-3rd-5th month)
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Locations

Country	Name	City	State
China	Department of Nephrology,Dongguan People's Hospital	Dongguan	Guangdong
China	Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University	Guangzhou	Guangdong
China	Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Department of Nephrology,Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Department of Nephrology,1st Affiliated Hospital,Shenzhen University	Shenzhen	Guangdong
China	Department of Nephrology,1st People's Hospital of Zhaoqing	Zhaoqing	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of proteinuria (complete or partial)		up to 6 months	Yes
Secondary	Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).		up to 6 months	Yes
Secondary	The longitudinal decline of kidney function(eGFR)		up to 6 months	Yes