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

IgA Nephropathy Clinical Trial

Official title:

Oxford Classification and Clinical Remission After Initial Treatments in Patients With IgA Nephropathy：a Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05528991
• Other study ID #: 20223357009
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2022
• Source: Shenzhen Second People's Hospital
• Contact: Ricong Xu
• Phone: 0755-83366388-8058
• Email: xrc224[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 474
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Locations

Country	Name	City	State
China	Shenzhen Second People's hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Review. — View Citation

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	The rate of change in renal function: the estimated rate of change in glomerular filtration rate (eGFR).; The rate of change of urine protein: the rate of change of total urine protein/urine creatinine.	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