Steroids Therapy in IgA Nephropathy With Crescents

NCT04833374 | Unknown Phase 3

• 1 other identifier: 1010PY (2020) -51
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy

Keywords

IgA nephropathy; crescent; steroid; proteinuria; eGFR

Outcome Measures

Primary Outcomes (1)

• Complete remission of proteinuria

  Proteinuria\<0.3g/24h and stable renal function

  6 months

Secondary Outcomes (2)

• Partial remission of proteinuria

  6 months

• Deterioration of renal function

  6 months

Study Arms (2)

1-2-3 Group

EXPERIMENTAL

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

1-3-5 Group

ACTIVE COMPARATOR

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

Interventions

Methylprednisolone DRUG

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.

Also known as: Prednisone

1-2-3 Group; 1-3-5 Group

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 10093981 RESULT

• 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.

  PMID: 14694168 RESULT

• Wyatt RJ, Julian BA. IgA nephropathy. N Engl J Med. 2013 Jun 20;368(25):2402-14. doi: 10.1056/NEJMra1206793. No abstract available.

  PMID: 23782179 RESULT

• 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.

  PMID: 28341274 RESULT

• 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.

  PMID: 11877568 RESULT

• 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.

  PMID: 10676716 RESULT

• 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.

  PMID: 26630142 RESULT

• 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.

  PMID: 28763548 RESULT

• Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.

  PMID: 38864363 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria

Interventions

Methylprednisolone; Prednisone

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; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Central Study Contacts

Mengjun Liang, MM

CONTACT

86-020-38379727; liangmj7@mail.sysu.edu.cn

Zongpei Jiang, MD,PhD

CONTACT

86-020-38379727; jiangzp@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 6, 2021
• Study Start: May 24, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)