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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhi-Hong Liu, M.D., Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT01451710
First received: October 7, 2011
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention
IgA Nephropathy
 Drug: Prednisone or Prednisolone

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • 24h urinary protein excretion [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • remission rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prednisone or Prednisolone 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
Other Name: Prednisone, prednisolone, corticosteroids

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451710

Locations
China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Study Director: Zhihong Liu, MD Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
  More Information

No publications provided

Responsible Party: Zhi-Hong Liu, M.D., Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT01451710     History of Changes
Other Study ID Numbers: NJCT-1102
Study First Received: October 7, 2011
Last Updated: July 9, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:
enough steroids
MCD
efficacy

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Nephrosis, Lipoid
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Nephrosis
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisone
 Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013