Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy
|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
|Condition or disease||Intervention/treatment||Phase|
|IgA Nephropathy||Procedure: tonsillectomy Other: non-tonsillectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: tonsillectomy group
The case group will receive 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.
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.
- 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
- 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 )
- 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 )
- Repeat renal biopsy [ Time Frame: the fifth and tenth year after tonsillectomy ]reevaluate the renal histological changes by the Lee's glomerular grading
- Side effects [ Time Frame: every 3-12months for 10 years after tonsillectomy ]The shortterm and longterm side effects of tonsillectomy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471599
|The First Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510000|
|Principal Investigator:||Xueqing Yu, MD||Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University|