Oxford Classification and Clinical Remission After Initial Treatments in Patients With IgA Nephropathy

NCT05528991 | Unknown

• 1 other identifier: 20223357009
• Study Type: observational
• Target: 474
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy (IgAN) is the most common form of primary glomerulonephritis and one of the leading causes of end-stage renal disease in China. The clinical manifestations of IgAN varies widely among individuals, and renal pathology is crucial for determining the severity of renal damage and predicting the renal progression. However, the association between renal pathology and patient response to medication has not been reported, and the majority of earlier RCT studies have not taken renal pathology into consideration when enrolling patients. The Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group, one of the most prestigious kidney disease organizations in the world, claims that there is not enough evidence to support the use of Oxford Classification to decide whether to administer immunosuppressive therapy to patients with IgAN.Therefore, the goal of this study was to investigate the relationship between Oxford Classification and clinical remission rates following initial teatments in patients with IgAN, with the aim of providing a basis for individualized clinical treatment plans. This study was a single-center prospective cohort study, and patients who were hospitalized in Shenzhen Second People's Hospital from January 2011 to January 2021 and diagnosed as IgAN by renal biopsy were collected continuously and followed up until December 2022. Cox regression models were used to analyze the effect of different Oxford Classifications on the clinical remission rates of patients at 6, 12, 18, and 24 months of treatments, and the relationship between Oxford Classification and secondary outcome indicators such as long-term renal function and urinary protein changes were analyzed using generalized additive mixed models.

Conditions

IgA Nephropathy

Keywords

IgA nephropathy; Oxford Classification; clinical remission rate

Outcome Measures

Primary Outcomes (1)

• Clinical remission rates (including complete and partial clinical remission rates) at 6, 12, 18, and 24 months for IgAN patients with different Oxford pathology scores (M, E, S, T, C) after being treated with the initial treatments.

  Complete clinical remission: 24h urine protein \<0.2g/d (or total urine protein/urine creatinine \<0.2g/g) . Partial clinical remission: ≥50% decrease in urine protein from baseline and urine protein \<1g/d (or total urine protein/urine creatinine \<1g/g).

  6, 12, 18, and 24 months after being treated with the initial treatments.

Secondary Outcomes (1)

• The longitudinal changes in renal function and urinary protein in IgAN patients with different Oxford Classification scores (M, E, S, T, C) after the initial treatments.

  During the follow-up period, the study will be terminated if the patient is transferred to renal transplantation, hemodialysis, peritoneal dialysis, or other centers, and the remaining patients will be followed until December 31, 2022

Study Arms (5)

mesangial hypercellularity, M

the histopathology was graded based on the revised Oxford Classification system as follows: M absent (M0) or M present (M1)

endocapillary hypercellularity, E

E absent (E0) or E present (E1)

segmental glomerulosclerosis, S

S absent (S0) or S present (S1)

tubular atrophy/interstitial fibrosis, T

T ≤ 25% (T0) or T 26%-50% (T1), or T \> 50% (T2)

crescents, C

C absent (C0) or C present ≥ 1 glomerulus (C1) or C \> 25% glomeruli (C2)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients admitted to Shenzhen Second People's Hospital from January 2011 to January 2021 with IgAN confirmed by renal biopsy were included.

You may qualify if:

• Age≥18 years；
• Initial renal biopsy；
• Glomeruli\>8；
• eGFR\>15ml/min；
• Proteinuria/creatinine ratio（PCR）\>0.5g/g

You may not qualify if:

• Secondary IgAN
• Combined with other kidney diseases
• Combined with acute kidney injury
• Combined with tumor
• Followed-up time \<6 months

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

Shenzhen Second People's hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available.

  PMID: 34556256 BACKGROUND

• Coppo R. Towards a personalized treatment for IgA nephropathy considering pathology and pathogenesis. Nephrol Dial Transplant. 2019 Nov 1;34(11):1832-1838. doi: 10.1093/ndt/gfy338.

  PMID: 30476257 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, IGA

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

Study Officials

• Qijun Wan

  Shenzhen Second People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Ricong Xu

CONTACT

0755-83366388-8058; xrc224@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: June 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2025
• Last Updated: September 6, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 1 year after publication

Locations

CN (1)