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Steroids Therapy in IgA Nephropathy With Crescents

Primary Purpose

IgA Nephropathy

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Methylprednisolone
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring IgA nephropathy, crescent, steroid, proteinuria, eGFR

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 14~65 years, regardless of gender
  2. Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with crescents.
  3. Average urinary protein excretion of 0.3~3.5g/24h on two successive examinations.
  4. eGFR≥30 ml/min/1.73m2.
  5. Willingness to sign an informed consent.

Exclusion Criteria:

  1. Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B-associated nephritis, etc.
  2. Rapidly progressive nephritic syndrome (crescent formation≥50%).
  3. Acute renal failure, including rapidly progressive IgAN.
  4. Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
  5. Date of renal biopsy exceeds more than 30 days.
  6. Cirrhosis, chronic active liver disease, and serious liver function damage.
  7. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).
  8. Any Active systemic infection or history of serious infection within one month.
  9. 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).
  10. Active tuberculosis
  11. Malignant hypertension that is difficult to be controlled by oral drugs.
  12. Known allergy, contraindication or intolerance to the steroids.
  13. Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.
  14. Malignant tumors.
  15. Excessive drinking or drug abuse.
  16. Mental aberrations.
  17. Current or recent (within 30 days) exposure to any other investigational drugs.
  18. Current use of RAS inhibitors needs to be eluted for at least 1 week before participating in the study.

Sites / Locations

  • Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1-2-3 Group

1-3-5 Group

Arm Description

Patients in 1-2-3Group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month, then oral prednisone 0.5mg/kg/d on alternate days for 6 months.

Patients in 1-3-5 Group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral prednisone 0.5mg/kg/d on alternate days for 6 months.

Outcomes

Primary Outcome Measures

Complete remission of proteinuria
Proteinuria<0.3g/24h and stable renal function

Secondary Outcome Measures

Partial remission of proteinuria
Proteinuria decline>50%, serum albumin>30g/L and stable renal function
Deterioration of renal function
The longitudinal decline of eGFR, serum creatinine arise>50%, or eGFR decline>25%, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation

Full Information

First Posted
April 4, 2021
Last Updated
June 2, 2021
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04833374
Brief Title
Steroids Therapy in IgA Nephropathy With Crescents
Official Title
Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with crescents.
Detailed 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. However, according to Oxford classification, crescents in IgAN 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 prednisone 0.5mg/kg/d on alternate days. Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral prednisone 0.5mg/kg/d on alternate days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
IgA nephropathy, crescent, steroid, proteinuria, eGFR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1-2-3 Group
Arm Type
Experimental
Arm Description
Patients in 1-2-3Group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month, then oral prednisone 0.5mg/kg/d on alternate days for 6 months.
Arm Title
1-3-5 Group
Arm Type
Active Comparator
Arm Description
Patients in 1-3-5 Group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral prednisone 0.5mg/kg/d on alternate days for 6 months.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Prednisone
Intervention Description
Patients will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd or 1st-3rd-5th month, then oral prednisone 0.5mg/kg/d on alternate days for 6 months.
Primary Outcome Measure Information:
Title
Complete remission of proteinuria
Description
Proteinuria<0.3g/24h and stable renal function
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Partial remission of proteinuria
Description
Proteinuria decline>50%, serum albumin>30g/L and stable renal function
Time Frame
6 months
Title
Deterioration of renal function
Description
The longitudinal decline of eGFR, serum creatinine arise>50%, or eGFR decline>25%, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 14~65 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with crescents. Average urinary protein excretion of 0.3~3.5g/24h on two successive examinations. eGFR≥30 ml/min/1.73m2. Willingness to sign an informed consent. Exclusion Criteria: Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B-associated nephritis, etc. 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, and serious liver function damage. 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. Current use of RAS inhibitors needs to be eluted for at least 1 week before participating in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mengjun Liang, MM
Phone
86-020-38379727
Email
liangmj7@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zongpei Jiang, MD,PhD
Phone
86-020-38379727
Email
jiangzp@mail.sysu.edu.cn
Facility Information:
Facility Name
Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Hu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10093981
Citation
Pozzi C, Bolasco PG, Fogazzi GB, Andrulli S, Altieri P, Ponticelli C, Locatelli F. Corticosteroids in IgA nephropathy: a randomised controlled trial. Lancet. 1999 Mar 13;353(9156):883-7. doi: 10.1016/s0140-6736(98)03563-6.
Results Reference
result
PubMed Identifier
14694168
Citation
Pozzi C, Andrulli S, Del Vecchio L, Melis P, Fogazzi GB, Altieri P, Ponticelli C, Locatelli F. Corticosteroid effectiveness in IgA nephropathy: long-term results of a randomized, controlled trial. J Am Soc Nephrol. 2004 Jan;15(1):157-63. doi: 10.1097/01.asn.0000103869.08096.4f.
Results Reference
result
PubMed Identifier
23782179
Citation
Wyatt RJ, Julian BA. IgA nephropathy. N Engl J Med. 2013 Jun 20;368(25):2402-14. doi: 10.1056/NEJMra1206793. No abstract available.
Results Reference
result
PubMed Identifier
28341274
Citation
Trimarchi H, Barratt J, Cattran DC, Cook HT, Coppo R, Haas M, Liu ZH, Roberts IS, Yuzawa Y, Zhang H, Feehally J; IgAN Classification Working Group of the International IgA Nephropathy Network and the Renal Pathology Society; Conference Participants. Oxford Classification of IgA nephropathy 2016: an update from the IgA Nephropathy Classification Working Group. Kidney Int. 2017 May;91(5):1014-1021. doi: 10.1016/j.kint.2017.02.003. Epub 2017 Mar 22.
Results Reference
result
PubMed Identifier
11877568
Citation
Hotta O, Furuta T, Chiba S, Tomioka S, Taguma Y. Regression of IgA nephropathy: a repeat biopsy study. Am J Kidney Dis. 2002 Mar;39(3):493-502. doi: 10.1053/ajkd.2002.31399.
Results Reference
result
PubMed Identifier
10676716
Citation
Shoji T, Nakanishi I, Suzuki A, Hayashi T, Togawa M, Okada N, Imai E, Hori M, Tsubakihara Y. Early treatment with corticosteroids ameliorates proteinuria, proliferative lesions, and mesangial phenotypic modulation in adult diffuse proliferative IgA nephropathy. Am J Kidney Dis. 2000 Feb;35(2):194-201. doi: 10.1016/s0272-6386(00)70326-x.
Results Reference
result
PubMed Identifier
26630142
Citation
Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B, Panzer U, Peters H, Benck U, Mertens PR, Kuhlmann U, Witzke O, Gross O, Vielhauer V, Mann JF, Hilgers RD, Floege J; STOP-IgAN Investigators. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. N Engl J Med. 2015 Dec 3;373(23):2225-36. doi: 10.1056/NEJMoa1415463.
Results Reference
result
PubMed Identifier
28763548
Citation
Lv J, Zhang H, Wong MG, Jardine MJ, Hladunewich M, Jha V, Monaghan H, Zhao M, Barbour S, Reich H, Cattran D, Glassock R, Levin A, Wheeler D, Woodward M, Billot L, Chan TM, Liu ZH, Johnson DW, Cass A, Feehally J, Floege J, Remuzzi G, Wu Y, Agarwal R, Wang HY, Perkovic V; TESTING Study Group. Effect of Oral Methylprednisolone on Clinical Outcomes in Patients With IgA Nephropathy: The TESTING Randomized Clinical Trial. JAMA. 2017 Aug 1;318(5):432-442. doi: 10.1001/jama.2017.9362.
Results Reference
result

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Steroids Therapy in IgA Nephropathy With Crescents

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