Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:

Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy :a Prospective,Randomized,Controlled Study.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02471599
• Other study ID #: SYSU-PRGNSIgAN-003
• Status: Suspended
• Phase: N/A
• Start date: March 2011
• Est. completion date: March 2023

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

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.

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Remission of proteinuria (complete or partial)	The remission rate of proteinuria (include complete or partial remission )	every 3-12months for 10 years after tonsillectomy
Secondary	Remission of hematuria (complete or partial)	The remission rate of hematuria (include complete or partial remission )	every 3-12months for 10 years after tonsillectomy
Secondary	Repeat renal biopsy	reevaluate the renal histological changes by the Lee's glomerular grading	the fifth and tenth year after tonsillectomy
Secondary	Side effects	The shortterm and longterm side effects of tonsillectomy.	every 3-12months for 10 years after tonsillectomy