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SuspendedNCT02471599Updated Sep 23, 2021

Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy

An interventional study of tonsillectomy and non-tonsillectomy in IgA Nephropathy, sponsored by Sun Yat-sen University. Suspended at 1 site in China. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-09-23.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

Why this study was suspended
This study was suspended because that few participants was enrolled.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
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Study 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.

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Conditions studied

  • IgA Nephropathy

Keywords

  • IgA nephropathy
  • tonsillitis
  • tonsil provocation test
  • Tonsillectomy
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    tonsillectomy group

    The case group will receive tonsillectomy.

    Procedure: tonsillectomy

  • Active comparator
    non-tonsillectomy group

    The controlled group will not receive tonsillectomy.

    Other: non-tonsillectomy

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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Every 12months for 10 years after tonsillectomy

Secondary outcomes

  1. Remission of proteinuria (complete or partial)

    The remission rate of proteinuria (include complete or partial remission )

    Time frame: every 3-12months for 10 years after tonsillectomy

  2. Remission of hematuria (complete or partial)

    The remission rate of hematuria (include complete or partial remission )

    Time frame: every 3-12months for 10 years after tonsillectomy

  3. Repeat renal biopsy

    reevaluate the renal histological changes by the Lee's glomerular grading

    Time frame: the fifth and tenth year after tonsillectomy

  4. Side effects

    The shortterm and longterm side effects of tonsillectomy.

    Time frame: every 3-12months for 10 years after tonsillectomy

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Study locations

1 site
  • The First Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02471599
Lead sponsor
Sun Yat-sen University
Responsible party
Xue Qing Yu (Professor, Sun Yat-sen University) — Principal investigator
First posted
Jun 15, 2015
Start date
Mar 2011
Primary completion
Mar 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Sep 23, 2021

Study contacts

Xueqing Yu, MD
principal investigator · Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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