The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:

The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451710
• Other study ID #: NJCT-1102
• Status: Completed
• Phase: N/A
• First received: October 7, 2011
• Last updated: July 9, 2012
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a single center,prospective,no-controlled clinical trial

Description:

1. The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

2. The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Female or male patients aged between 18 to 65 years

• Renal biopsy was used to diagnose IgA nephropathy

• Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L

Exclusion Criteria:

• Patients with serum creatinine = 3 mg/dl or eGFR < 30ml/min per 1.73 m2

• urine RBC > 1 million/ml

• Patients who have received treatment of enough steroids for more than 12 weeks

• patients with secondary IgA

• Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis

• Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases
• Nephrosis, Lipoid

Intervention

Drug:
• Prednisone or Prednisolone
daily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24h urinary protein excretion		3 months	Yes
Secondary	remission rate		3 months	Yes