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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]

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

Condition category

Condition code

Renal and Urogenital

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 The dose of PSL was withdrawn by 10 mg alternative day every 2 months and finally discontinued at 6th month.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]

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]

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]

6 months, 12 months and 24 months following randomisation

Primary outcome [2]

Reduction rate of proteinuria and hematuria, which is assess morning urine by urine analysis and chemistry

Timepoint [2]

6 months, 12 months and 24 months following randomisation

Secondary outcome [1]

Change in kidney function, which is assessed by estimated glomerular filtration rate (eGFR)

Timepoint [1]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/04/2007

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]

Japan

State/province [1]

Okinawa

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of the Ryukyus

Address [1]

207, uehara, Nishihara-cho, Okinawa 903-0215

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The ethics review board of the University of the Ryukyus

Ethics committee address [1]

207, uehara, Nishihara-cho, Okinawa 903-0215

Ethics committee country [1]

Japan

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Kentaro Kohagura

Address

Department of Cardiovascular Medicine, Nephrology and Neurology, University of The Ryukyus, 207 Uehara, Nishihara-cho, Okinawa 903-0215, Japan

Country

Japan

Phone

+81 98 895 1150

Fax

+81 98 895 1416

kohagura@med.u-ryukyu.ac.jp

Contact person for scientific queries

Name

Dr. Yusuke, Ohya

Address

Department of Cardiovascular Medicine, Nephrology, Neurology, University of Ryukyus, 207 Uehara, Nishihara-cho, Okinawa 903-0215, Japan

Country

Japan

Phone

+81 98 895 1150

Fax

+81 98 895 1416

ohaya@med.u-ryukyu.ac.jp

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Basic results	No		320563-(Uploaded-27-11-2020-14-15-02)-Basic results summary.docx
Plain language summary	No	Baseline proteinuria (g/g Cr) were comparable betw... [More Details]
Study results article	Yes	Add-On Effect of Angiotensin Receptor Blockade (C... [More Details]	320563-(Uploaded-27-11-2020-14-20-35)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Add-On Effect of Angiotensin Receptor Blockade (Candesartan) on Clinical Remission in Active IgA Nephropathy Patients Treated with Steroid Pulse Therapy and Tonsillectomy: a Randomized, Parallel-Group Comparison Trial	2018	https://doi.org/10.1159/000489914

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically