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Trial registered on ANZCTR


Registration number
ACTRN12610000516088
Ethics application status
Approved
Date submitted
27/04/2010
Date registered
22/06/2010
Date last updated
22/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Candesartan combined with steroid pulse therapy and tonsillectomy on clinical remission in Immunoglobulin A (IgA) nephropathy
Scientific title
Multicenter, Randomized, Parallel study of Angiotensin Receptor blockade (Candesartan) Combined with Steroid Pulse Therapy and Tonsillectomy in Immunoglobulin A (IgA) nephropathy Patients to assess remission rate and improvement rate of proteinuria and hematuria
Secondary ID [1] 1073 0
Cochrane Renal Group 120700128
Universal Trial Number (UTN)
Trial acronym
Combination Therapy, Candesartan, Steroid pulse and Tonsillectomy in Ig A nephropathy (CAST IgA )
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA nephropathy 257154 0
Condition category
Condition code
Renal and Urogenital 257305 257305 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Candesartan, which is added on the control treatment (steroid pulse therapy, tonsillectomy and antiplatelets )
Candesartan and steroid pulse therapy administered simultaneously from baseline to 6 months, tonsilectomy done between 1-6 months, and candesartan restarted if necessary from 12-24 months.
1. Candesartan: it is started with the dose of 2-8mg oral tablet once daily and increased the dose up to 12 mg once daily if patients did not achieve remission of proteinuria for 6 months. The dose prescribed at discretion of treating clinician based on individual patient characteristics.
2. steroid pulse therapy: a) methyl prednisolone 500 mg/d b) intravenousy administered for serial 3 days followed by oral prednisolone (PSL) 30 mg/d for subsequent 4 days. c) three courses for initial serial 3 weeks followed by oral PSL 30 mg once alternative day for next 2 months. The dose of PSL was withdrawn by 10 mg alternative day every 2 months and finally discontinued at 6th month.
3. Tonsillectomy: it is done between 1-6 months by otorhinolaryngologist.
4. Antiplatelets (dilazep dihydrochloride): it is administerd orally at a dose of 300 mg /day for 24 months.
5. At 12th month, candesartan is restarted if patients did not achieve remission of proteinuria.Candesartan is restarted with the dose of 2-8mg oral tablet once daily and increased the dose up to 12 mg once daily if patients did not achieve remission of proteinuria for next 12 months. The dose prescribed at discretion of treating clinician based on individual patient characteristics.
Intervention code [1] 241358 0
Treatment: Drugs
Comparator / control treatment
Control treatment : steroid pulse therapy and tonsillectomy and antiplatelets
Description of each treatments are described in " Description of intervention(s) ".

At 12th month, candesartan is started, similarly to intervention group, if patients did not achieve remission of proteinuria.
Control group
Active

Outcomes
Primary outcome [1] 240857 0
Remission rate of proteinuria and hematuria
1) assess morning urine by urine analysis and chemistry
2) definition of remission
a) proteinuria: urinary protein less than 0.2 g/gCr
b) hemeturia : urinary renal blood cell counts less than 5/ high power field
Timepoint [1] 240857 0
6 months, 12 months and 24 months following randomisation
Primary outcome [2] 253003 0
Reduction rate of proteinuria and hematuria, which is assess morning urine by urine analysis and chemistry
Timepoint [2] 253003 0
6 months, 12 months and 24 months following randomisation
Secondary outcome [1] 257527 0
Change in kidney function, which is assessed by estimated glomerular filtration rate (eGFR)
Timepoint [1] 257527 0
6 months, 12 months and 24 months following randomisation

Eligibility
Key inclusion criteria
1.Histologically proven Ig A nephropathy patients

2.Serum creatinine levels is < 1.5 mg/dl

3.Urinary protein excretion is equal to and more than 0.5g/g creatinine and

urinary red blood cell counts is equal to and more than 10/high power field

4.Histologically proven focal active lesion
Minimum age
15 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Recent onset of cardiovascular disease 2.Severe hypertension (high systolic blood pressure >200mmHg or high diastolic blood pressure >100mmHg

3.Diabetes mellitus

4.Patient on angiotensin converting enzyme inhibitors (ACEI) or other angiotensin receptor blockades (ARB)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization by using a permuted-block method with stratification according to proteinuria and years of disease onset
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2110 0
Japan
State/province [1] 2110 0
Okinawa

Funding & Sponsors
Funding source category [1] 256806 0
University
Name [1] 256806 0
University of the Ryukyus
Address [1] 256806 0
207, uehara, Nishihara-cho, Okinawa 903-0215
Country [1] 256806 0
Japan
Primary sponsor type
University
Name
Cardiovascular medicine, nephrology and neurology, University of the Ryukyus
Address
207, uehara, Nishihara-cho, Okinawa 903-0215
Country
Japan
Secondary sponsor category [1] 256088 0
None
Name [1] 256088 0
Address [1] 256088 0
Country [1] 256088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258995 0
The ethics review board of the University of the Ryukyus
Ethics committee address [1] 258995 0
207, uehara, Nishihara-cho, Okinawa 903-0215
Ethics committee country [1] 258995 0
Japan
Date submitted for ethics approval [1] 258995 0
Approval date [1] 258995 0
Ethics approval number [1] 258995 0

Summary
Brief summary
Remission of hematuria and proteinuria is a strong predictor of stable renal function in IgA nephropathy. Steroid pulse therapy combined with tonsilectomy can achieve relatively higher remission rate of hematuria and proteinuria in IgA nephropathy. Some of the patients can maintain the remission even after discontinuation of drug therapy. Drug-free remission may be critical for patients, especially younger women. We conduct the study to evaluate the effectiveness of Candesartan combined with steroid pulse therapy and tonsillectomy on clinical remission in IgA nephropathy. Additionally, we evaluate the efficacy of Candesartan, the dose of which is increased regardless of blood pressure, on the remission rate in the patients, who do not achieve the remission by the combination steroid pulse therapy and tonsilectomy .
Trial website
Trial related presentations / publications
1 Hotta O, et al: Tonsillectomy and steroid pulse therapy significantly impact on clinical remission in patients with IgA nephropathy. Am J Kidney Dis 38: 736-743, 2001

2 Miyazaki M et al: A multicenter prospective cohort study of tonsillectomy and steroid therapy in Japanese patients with IgA nephropathy: A 5-year Report. Contrib Nephrol 157: 94-98, 2007
Public notes

Contacts
Principal investigator
Name 30242 0
Address 30242 0
Country 30242 0
Phone 30242 0
Fax 30242 0
Email 30242 0
Contact person for public queries
Name 13489 0
Dr. Kentaro Kohagura
Address 13489 0
Department of Cardiovascular Medicine, Nephrology and Neurology, University of The Ryukyus, 207 Uehara, Nishihara-cho, Okinawa 903-0215, Japan
Country 13489 0
Japan
Phone 13489 0
+81 98 895 1150
Fax 13489 0
+81 98 895 1416
Email 13489 0
kohagura@med.u-ryukyu.ac.jp
Contact person for scientific queries
Name 4417 0
Dr. Yusuke, Ohya
Address 4417 0
Department of Cardiovascular Medicine, Nephrology, Neurology, University of Ryukyus, 207 Uehara, Nishihara-cho, Okinawa 903-0215, Japan
Country 4417 0
Japan
Phone 4417 0
+81 98 895 1150
Fax 4417 0
+81 98 895 1416
Email 4417 0
ohaya@med.u-ryukyu.ac.jp

No information has been provided regarding IPD availability
Summary results
No Results