The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04438603
• Date of registration: 17/06/2020
• Prospective Registration: Yes
• Primary sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Public title: The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
• Scientific title: The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
• Date of first enrolment: October 1, 2020
• Target sample size: 180
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04438603
• Study type: Observational

Countries of recruitment

China

Contacts

• Name: Jiang Gengru

Key inclusion & exclusion criteria

Inclusion Criteria:

1. IgA nephropathy:

1. Age: 18-80 years.

2. Patients diagnosed with primary IgA nephropathy by renal biopsy.

3. Estimated glomerular filtration rate (using the 2009 CKD-EPI formula)
=30ml/min/1.73/m^2.

4. Obtain informed consent from patients. 2. Healthy Control: Gender, age and ethnicity
matched health volunteers. 3. IgAN patients were further divided into 4 groups, as
defined below:

1) Long-term stable patients:

Follow-up for at least 15 years and meet at least one of the following:

1. Annual eGFR loss rate <3ml/min/1.73m^2.

2. eGFR>90ml/min/1.73m^2. 2) Non-progressive IgAN patients:

Meet at least one of the following:

1. eGFR decrease of more than 50% from baseline (in the absence of other possible causes
of kidney damage).

2. Annual eGFR loss rate >5ml/min/1.73m^2.

3. Progress to ESRD. 3) IgAN patients at low risk of disease progression: Proteinuria =
1g/24h after 3 months of optimized supportive care. 4) IgAN patients at high risk of
disease progression: Proteinuria > 1g/24h despite 3 months of optimized supportive
care.

Exclusion Criteria:

1. Kidney biopsy shows crescentic IgAN or MCD-IgAN.;

2. Patients with secondary IgAN;

3. During pregnancy or lactation;

4. After kidney transplantation;

5. More than one serious acute infection in the psat 12 months;

6. Chronic infection;

7. Use of glucocorticosteroids and other immunosuppressive drugs within the last 6
months;

8. Incomplete medical history or clinical data.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Intervention(s)

Drug: Intervention for patients at high risk of disease progression

Drug: Intervention for incipient patients at low risk of disease progression

Primary Outcome(s)

Urinary protein remission rate [Time Frame: 24 weeks]

Secondary Outcome(s)

24-hour urine protein level [Time Frame: 24 weeks]

Serum albumin level [Time Frame: 24 weeks]

eGFR (estimated using the 2009 CKD-EPI formula) [Time Frame: 24 weeks]

Secondary ID(s)

XHEC-C-2020-070-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

RenJi Hospital

Shanghai Zhongshan Hospital