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Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471599
Recruitment Status : Suspended (This study was suspended because that few participants was enrolled.)
First Posted : June 15, 2015
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Procedure: tonsillectomy Other: non-tonsillectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy :a Prospective,Randomized,Controlled Study.
Study Start Date : March 2011
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tonsillectomy group
The case group will receive tonsillectomy.
Procedure: 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.

Active Comparator: non-tonsillectomy group
The controlled group will not receive tonsillectomy.
Other: 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Remission of proteinuria (complete or partial) [ Time Frame: every 3-12months for 10 years after tonsillectomy ]
    The remission rate of proteinuria (include complete or partial remission )

  2. Remission of hematuria (complete or partial) [ Time Frame: every 3-12months for 10 years after tonsillectomy ]
    The remission rate of hematuria (include complete or partial remission )

  3. Repeat renal biopsy [ Time Frame: the fifth and tenth year after tonsillectomy ]
    reevaluate the renal histological changes by the Lee's glomerular grading

  4. Side effects [ Time Frame: every 3-12months for 10 years after tonsillectomy ]
    The shortterm and longterm side effects of tonsillectomy.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471599


Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Xueqing Yu, MD Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02471599    
Other Study ID Numbers: SYSU-PRGNSIgAN-003
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Keywords provided by Xue Qing Yu, Sun Yat-sen University:
IgA nephropathy
tonsillitis
tonsil provocation test
Tonsillectomy
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases