NCT02471599

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

12 years

First QC Date

May 19, 2015

Last Update Submit

September 21, 2021

Conditions

IgA Nephropathy

Keywords

IgA nephropathytonsillitistonsil provocation testTonsillectomy

Outcome Measures

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

    Every 12months for 10 years after tonsillectomy

Secondary Outcomes (4)

  • Remission of proteinuria (complete or partial)

    every 3-12months for 10 years after tonsillectomy

  • Remission of hematuria (complete or partial)

    every 3-12months for 10 years after tonsillectomy

  • Repeat renal biopsy

    the fifth and tenth year after tonsillectomy

  • Side effects

    every 3-12months for 10 years after tonsillectomy

Study Arms (2)

tonsillectomy group

EXPERIMENTAL

The case group will receive tonsillectomy.

Procedure: tonsillectomy

non-tonsillectomy group

ACTIVE COMPARATOR

The controlled group will not receive tonsillectomy.

Other: non-tonsillectomy

Interventions

tonsillectomyPROCEDURE

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.

tonsillectomy group
non-tonsillectomyOTHER

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.

non-tonsillectomy group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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）

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

  • Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.

    PMID: 38864363DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGATonsillitis

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesPharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Xueqing Yu, MD

    Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2015

First Posted

June 15, 2015

Study Start

March 1, 2011

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

CN(1)