Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy

Study Overview
=================
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.

Official Title
-----------------
Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy :a Prospective,Randomized,Controlled Study.

Conditions
-----------------
IgA Nephropathy

Intervention / Treatment
-----------------
* Procedure: tonsillectomy
* Other: non-tonsillectomy


Participation Criteria
=================
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）

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tonsillectomy group<br>The case group will receive tonsillectomy. | Procedure: tonsillectomy<br>* 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.<br>|
| Active Comparator: non-tonsillectomy group<br>The controlled group will not receive tonsillectomy. | Other: non-tonsillectomy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal survival rate or Deterioration of renal function | Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline estimated glomerular filtration rate (eGFR) levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation)after tonsillectomy | Every 12months for 10 years after tonsillectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission of proteinuria (complete or partial) | The remission rate of proteinuria (include complete or partial remission ) | every 3-12months for 10 years after tonsillectomy | 
| Remission of hematuria (complete or partial) | The remission rate of hematuria (include complete or partial remission ) | every 3-12months for 10 years after tonsillectomy | 
| Repeat renal biopsy | reevaluate the renal histological changes by the Lee's glomerular grading | the fifth and tenth year after tonsillectomy | 
| Side effects | The shortterm and longterm side effects of tonsillectomy. | every 3-12months for 10 years after tonsillectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgA nephropathy, tonsillitis, tonsil provocation test, Tonsillectomy