IgA NephropathyNCT02471599
Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy
A study testing tonsillectomy and non-tonsillectomy in people with IgA Nephropathy, run by Sun Yat-sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- tonsillectomy and non-tonsillectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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）
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy :a Prospective,Randomized,Controlled Study.
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.
- Conditions
- IgA Nephropathy
- Being tested
- tonsillectomy, non-tonsillectomy
- Keywords
- IgA nephropathy, tonsillitis, tonsil provocation test, Tonsillectomy
- Medical subject headings
- Glomerulonephritis, IGA, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tonsillectomyProcedure or surgery
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| tonsillectomy group | Experimental | The case group will receive tonsillectomy. Receives: Procedure: tonsillectomy |
| non-tonsillectomy group | Active comparator | The controlled group will not receive tonsillectomy. Receives: Other: non-tonsillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 12months for 10 years after tonsillectomy
Secondary outcomes (4)
Remission of proteinuria (complete or partial)
The remission rate of proteinuria (include complete or partial remission )
Measured: every 3-12months for 10 years after tonsillectomy
Remission of hematuria (complete or partial)
The remission rate of hematuria (include complete or partial remission )
Measured: every 3-12months for 10 years after tonsillectomy
Repeat renal biopsy
reevaluate the renal histological changes by the Lee's glomerular grading
Measured: the fifth and tenth year after tonsillectomy
Side effects
The shortterm and longterm side effects of tonsillectomy.
Measured: every 3-12months for 10 years after tonsillectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startMar 2011
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: This study was suspended because that few participants was enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xueqing Yu, MD, Principal investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471599
- Sponsor's protocol ID
- SYSU-PRGNSIgAN-003
- Status last verified
- Sep 2021
- First submitted
- 19 May 2015
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38864363
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy :a Prospective,Randomized,Controlled Study.
- ClinicalTrials.gov ID
- NCT02471599
- Acronym / sponsor ID
- SYSU-PRGNSIgAN-003
- Conditions
- IgA Nephropathy
- Keywords
- IgA nephropathy, tonsillitis, tonsil provocation test, Tonsillectomy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: This study was suspended because that few participants was enrolled.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tonsillectomy group | Experimental | Procedure: tonsillectomyThe case group will receive tonsillectomy. |
| non-tonsillectomy group | Active comparator | Other: non-tonsillectomyThe controlled group will not receive tonsillectomy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tonsillectomyThe 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. | Procedure or surgery | tonsillectomy group |
| non-tonsillectomyThe 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. | Other | non-tonsillectomy group |
Primary outcome
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
4 secondary outcomes
Remission of proteinuria (complete or partial)
Time frame: every 3-12months for 10 years after tonsillectomy
Remission of hematuria (complete or partial)
Time frame: every 3-12months for 10 years after tonsillectomy
Repeat renal biopsy
Time frame: the fifth and tenth year after tonsillectomy
Side effects
Time frame: every 3-12months for 10 years after tonsillectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 38864363Alladin 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.
Related trials for IgA Nephropathy
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueqing Yu, MD principal investigator
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tonsillectomy and non-tonsillectomy in people with IgA Nephropathy, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal survival rate or Deterioration of renal function (time frame: Every 12months for 10 years after tonsillectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.