Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy
Primary Purpose
IgA Nephropathy
Status
Suspended
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tonsillectomy
non-tonsillectomy
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy focused on measuring IgA nephropathy, tonsillitis, tonsil provocation test, Tonsillectomy
Eligibility 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)
Sites / Locations
- The First Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
tonsillectomy group
non-tonsillectomy group
Arm Description
The case group will receive tonsillectomy.
The controlled group will not receive tonsillectomy.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Remission of proteinuria (complete or partial)
The remission rate of proteinuria (include complete or partial remission )
Remission of hematuria (complete or partial)
The remission rate of hematuria (include complete or partial remission )
Repeat renal biopsy
reevaluate the renal histological changes by the Lee's glomerular grading
Side effects
The shortterm and longterm side effects of tonsillectomy.
Full Information
NCT ID
NCT02471599
First Posted
May 19, 2015
Last Updated
September 21, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02471599
Brief Title
Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy
Official Title
Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy :a Prospective,Randomized,Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Suspended
Why Stopped
This study was suspended because that few participants was enrolled.
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
IgA nephropathy, tonsillitis, tonsil provocation test, Tonsillectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tonsillectomy group
Arm Type
Experimental
Arm Description
The case group will receive tonsillectomy.
Arm Title
non-tonsillectomy group
Arm Type
Active Comparator
Arm Description
The controlled group will not receive tonsillectomy.
Intervention Type
Procedure
Intervention Name(s)
tonsillectomy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
non-tonsillectomy
Intervention Description
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 Measure Information:
Title
Renal survival rate or Deterioration of renal function
Description
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 Outcome Measure Information:
Title
Remission of proteinuria (complete or partial)
Description
The remission rate of proteinuria (include complete or partial remission )
Time Frame
every 3-12months for 10 years after tonsillectomy
Title
Remission of hematuria (complete or partial)
Description
The remission rate of hematuria (include complete or partial remission )
Time Frame
every 3-12months for 10 years after tonsillectomy
Title
Repeat renal biopsy
Description
reevaluate the renal histological changes by the Lee's glomerular grading
Time Frame
the fifth and tenth year after tonsillectomy
Title
Side effects
Description
The shortterm and longterm side effects of tonsillectomy.
Time Frame
every 3-12months for 10 years after tonsillectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueqing Yu, MD
Organizational Affiliation
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
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Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy
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