Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy

NCT ID: NCT02471599

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2023-03-31

Brief Summary

The effect of tonsillectomy therapy on IgA nephropathy is still controversial.Few prospective,randomized investigations have examined how tonsillectomy affects the shortterm and longterm renal outcome of IgA nephropathy.This is A prospective,randomized ,controlled study to explore the longterm effect of tonsillectomy for patients with IgA nephropathy.

Conditions

IgA Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tonsillectomy group

The case group will receive tonsillectomy.

Group Type: EXPERIMENTAL

tonsillectomy

Intervention Type: PROCEDURE

The tonsillectomy will be performed by the otolaryngologist. In addition, all subjects will receive the conventional drug treatments, defined as treatment of participants using the angiotensin-converting enzyme inhibitor (ACEi)/angiotensin II receptor blocker (ARB), anticoagulants, antihypertensives, corticosteroids so on, according to individual status.

non-tonsillectomy group

The controlled group will not receive tonsillectomy.

Group Type: ACTIVE_COMPARATOR

non-tonsillectomy

Intervention Type: OTHER

The non-tonsillectomy group received conventional drug treatments defined as treatment of participants using the ACEi/ARB,Anticoagulants, Antihypertensives, corticosteroids and so on, according to individual status.

Interventions

tonsillectomy

The tonsillectomy will be performed by the otolaryngologist. In addition, all subjects will receive the conventional drug treatments, defined as treatment of participants using the angiotensin-converting enzyme inhibitor (ACEi)/angiotensin II receptor blocker (ARB), anticoagulants, antihypertensives, corticosteroids so on, according to individual status.

Intervention Type: PROCEDURE

non-tonsillectomy

The non-tonsillectomy group received conventional drug treatments defined as treatment of participants using the ACEi/ARB,Anticoagulants, Antihypertensives, corticosteroids and so on, according to individual status.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Willingness to sign an informed consent
• Age:18~45 years, regardless of gender
• Clinical evaluation and renal biopsy diagnostic for immunoglobulin A nephropathy (IgAN), excluded secondary IgAN. Renal histological criteria should be defined by Lee's glomerular grading system.
• Any one of three Tonsilar conditions defined by Otorhinolaryngologist : 1,recurrent acute tonsillitis accompanied with gross hematuria or urinary findings abnormality；2,recurrent acute tonsillitis without gross hematuria，but tonsil provocation test was positive；3, No history of acute tonsillitis,body examination found hypertrophy or atrophy tonsils ,crypt pus of tonsils ,or scars on the tonsil surface ,and positive tonsil provocation test.
• Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2

Exclusion Criteria

• Inability or unwillingness to sign the informed consent
• Inability or unwillingness to meet the scheme demands raised by the investigators
• Rapidly progressive nephritic syndrome and acute renal failure, 24-hour urine protein≥3.5g,including rapidly progressive IgAN (IgAN with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents.
• Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis
• est GFR < 30 mL/min/1.73m2
• Malignant hypertension that is difficult to be controlled by oral drugs
• Cirrhosis, chronic active liver disease.
• 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 of entry or known infection with HIV, hepatitis B, or hepatitis C.
• 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)
• Malignant tumors (except fully cured basal cell carcinoma)
• Current or recent (within 30 days) exposure to any other investigation
• Current exposure to mycophenolic mofetil (MMF),azathioprine or corticosteroids. In case of current treatment with oral steroid ,entry is permitted after corticosteroids dosage below 0.4mg/kg per day.
• Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception
• Tonsillectomy had been done when IgAN diagnosis or known contraindication to tonsillectomy(such as neutropenia，bleeding tendency，or anatomic abnormalities）

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xue Qing Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xueqing Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 38864363 (View on PubMed)

Other Identifiers

SYSU-PRGNSIgAN-003

Identifier Type: -

Identifier Source: org_study_id