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

NCT ID: NCT05528991

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 474 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mesangial hypercellularity, M

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

No interventions assigned to this group

endocapillary hypercellularity, E

E absent (E0) or E present (E1)

No interventions assigned to this group

segmental glomerulosclerosis, S

S absent (S0) or S present (S1)

No interventions assigned to this group

tubular atrophy/interstitial fibrosis, T

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

No interventions assigned to this group

crescents, C

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qijun Wan

Role: STUDY_DIRECTOR

Shenzhen Second People's Hospital

Locations

Shenzhen Second People's hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ricong Xu

Role: CONTACT

xrc224@126.com

0755-83366388-8058

Facility Contacts

Ricong Xu

Role: primary

xrc224@126.com

0755-83366388-8058

References

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.

Reference Type: BACKGROUND

PMID: 28341274 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34556256 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30476257 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28763548 (View on PubMed)

Other Identifiers

20223357009

Identifier Type: -

Identifier Source: org_study_id