Steroids Therapy in IgA Nephropathy With Crescents

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ClinicalTrials.gov Identifier: NCT04833374

Recruitment Status : Recruiting

First Posted : April 6, 2021

Last Update Posted : June 4, 2021

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Sponsor:

Information provided by (Responsible Party):

Sixth Affiliated Hospital, Sun Yat-sen University

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.

Condition or disease	Intervention/treatment	Phase
IgA Nephropathy	Drug: Methylprednisolone	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Crescents : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.
Actual Study Start Date :	May 24, 2021
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases Steroids

Drug Information available for: Prednisolone Prednisolone acetate Prednisone Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

Genetic and Rare Diseases Information Center resources: IgA Nephropathy Glomerulonephritis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1-2-3 Group 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.	Drug: Methylprednisolone 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. Other Name: Prednisone
Active Comparator: 1-3-5 Group 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.	Drug: Methylprednisolone 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. Other Name: Prednisone

Outcome Measures

Primary Outcome Measures :

Complete remission of proteinuria [ Time Frame: 6 months ]
Proteinuria<0.3g/24h and stable renal function

Secondary Outcome Measures :

Partial remission of proteinuria [ Time Frame: 6 months ]
Proteinuria decline>50%, serum albumin>30g/L and stable renal function
Deterioration of renal function [ Time Frame: 6 months ]
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

Eligibility Criteria

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Ages Eligible for Study:	14 Years to 65 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833374

Contacts

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Contact: Mengjun Liang, MM	86-020-38379727	liangmj7@mail.sysu.edu.cn
Contact: Zongpei Jiang, MD,PhD	86-020-38379727	jiangzp@mail.sysu.edu.cn

Locations

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China, Guangdong
Sixth Affiliated Hospital, Sun Yat-sen University	Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Jun Hu

Sponsors and Collaborators

Sixth Affiliated Hospital, Sun Yat-sen University

More Information

Publications of Results:

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.

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.

Wyatt RJ, Julian BA. IgA nephropathy. N Engl J Med. 2013 Jun 20;368(25):2402-14. doi: 10.1056/NEJMra1206793. Review.

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. Review.

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.

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.

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.

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.

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Responsible Party:	Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT04833374
Other Study ID Numbers:	1010PY (2020) -51
First Posted:	April 6, 2021 Key Record Dates
Last Update Posted:	June 4, 2021
Last Verified:	June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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

Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:


IgA nephropathy crescent steroid proteinuria eGFR

Additional relevant MeSH terms:

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Kidney Diseases Glomerulonephritis, IGA Urologic Diseases Glomerulonephritis Nephritis Autoimmune Diseases Immune System Diseases Prednisone Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate Prednisolone Prednisolone acetate Prednisolone hemisuccinate	Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents

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