IgA Nephropathy
Conditions
Keywords
IgA nephropathy, tonsillitis, tonsil provocation test, Tonsillectomy
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.
Interventions
PROCEDUREtonsillectomy
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.
OTHERnon-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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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）
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal survival rate or Deterioration of renal function | Every 12months for 10 years after tonsillectomy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission of proteinuria (complete or partial) | every 3-12months for 10 years after tonsillectomy | The remission rate of proteinuria (include complete or partial remission ) |
| Remission of hematuria (complete or partial) | every 3-12months for 10 years after tonsillectomy | The remission rate of hematuria (include complete or partial remission ) |
| Repeat renal biopsy | the fifth and tenth year after tonsillectomy | reevaluate the renal histological changes by the Lee's glomerular grading |
| Side effects | every 3-12months for 10 years after tonsillectomy | The shortterm and longterm side effects of tonsillectomy. |
Countries
China
Outcome results
None listed