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

NCT01451710 | Completed DMC

• 1 other identifier: NJCT-1102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgA Nephropathy

Keywords

enough steroids; MCD; efficacy

Outcome Measures

Primary Outcomes (1)

• 24h urinary protein excretion

  3 months

Secondary Outcomes (1)

• remission rate

  3 months

Study Arms (1)

Prednisone or Prednisolone

EXPERIMENTAL

Drug: Prednisone or Prednisolone

Interventions

Prednisone or Prednisolone DRUG

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

Also known as: Prednisone, prednisolone, corticosteroids

Prednisone or Prednisolone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, China

Location

Related Publications (1)

• Wang J, Juan C, Huang Q, Zeng C, Liu Z. Corticosteroid therapy in IgA nephropathy with minimal change-like lesions: a single-centre cohort study. Nephrol Dial Transplant. 2013 Sep;28(9):2339-45. doi: 10.1093/ndt/gft211. Epub 2013 Jun 19.

  PMID: 23787555 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Macular dystrophy, corneal type 1

Interventions

Prednisone; Prednisolone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Zhihong Liu, MD

  Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 14, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

CN (1)