NCT02471599SuspendedNot Applicable
Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy :a Prospective,Randomized,Controlled Study.
Sun Yat-sen University1 site in 1 country100 target enrollmentStarted: March 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Renal survival rate or Deterioration of renal function
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts 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）
Arms & Interventions
tonsillectomy group
Experimental
The case group will receive tonsillectomy.
Intervention: tonsillectomy (Procedure)
non-tonsillectomy group
Active Comparator
The controlled group will not receive tonsillectomy.
Intervention: non-tonsillectomy (Other)
Outcomes
Primary Outcomes
Renal survival rate or Deterioration of renal function
Time Frame: 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 Outcomes
- Remission of proteinuria (complete or partial)(every 3-12months for 10 years after tonsillectomy)
- Repeat renal biopsy(the fifth and tenth year after tonsillectomy)
- Remission of hematuria (complete or partial)(every 3-12months for 10 years after tonsillectomy)
- Side effects(every 3-12months for 10 years after tonsillectomy)
Investigators
Xue Qing Yu
Professor
Sun Yat-sen University
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in AdultsObstructive Sleep ApneaSleep Apnea SyndromesTonsillar HypertrophyNCT05049369Turku University Hospital17
Withdrawn
Not Applicable
Impact of a History of Tonsillectomy or Adenoidectomy on the Severity of COVID-19 : AMYVID StudyTonsillectomyAdenoidectomyCOVID-19NCT05935566University Hospital, Angers
Withdrawn
Not Applicable
Outcomes of Partial Versus Complete Tonsillectomy for Obstructive Sleep Disordered BreathingObstructive Sleep Disordered BreathingNCT00519402The Cleveland Clinic
Completed
Phase 4
Recurrent Throat Infections and TonsillectomyTonsillitisPharyngitisNCT00547391Oulu University Hospital87
Completed
Phase 1
Evaluation of complication of tonsillectomy by Cold dissection versus bipolar diathermyChronic tonsillitis.Chronic diseases of tonsils and adenoidsIRCT2013102113976N2Hamedan University of Medical Sciences82