Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000996268
Ethics application status
Approved
Date submitted
17/11/2009
Date registered
31/03/2006
Date last updated
10/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized prospective trial of cyclosporine with/without low-dose prednisolone in idiopathic membranous nephropathy in adults with nephrotic syndrome
Scientific title
Randomized prospective trial of cyclosporine with/without low-dose prednisolone in idiopathic membranous nephropathy in adults with nephrotic syndrome
Secondary ID [1] 1138 0
Cochrane Renal Group-CRG030600062
Universal Trial Number (UTN)
Trial acronym
CYPMEN (CYclosporine with/without Prednisolone in MEmbranous Nephropathy) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
idiopathic membranous nephropathy with nephrotic syndrome 252229 0
Condition category
Condition code
Renal and Urogenital 252416 252416 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral administration of cyclosporine 3 mg/kg/day and prednisolone 15 mg/day, for a total of 24 months
Intervention code [1] 241562 0
Treatment: Drugs
Comparator / control treatment
Oral administration of cyclosporine 3 mg/kg/day. for a total of 24 months
Control group
Active

Outcomes
Primary outcome [1] 253290 0
Rates of patients with complete remission or partial remission, and rates of patients with relapse or recurrence by urinaly examinations at the follow-up clinic visiting
Timepoint [1] 253290 0
24 months after the initiation of the treatment
Secondary outcome [1] 262315 0
excretion of urinary protein (g/day)
Timepoint [1] 262315 0
until 24 months after the initiation of the treatment
Secondary outcome [2] 262316 0
serum levels of protein and albumin (mg/dL)
Timepoint [2] 262316 0
until 24 months after the initiation of the treatment
Secondary outcome [3] 262317 0
creatinine clearance (mL/min)
Timepoint [3] 262317 0
until 24 months after the initiation of the treatment
Secondary outcome [4] 262318 0
serum creatinine level (mg/dL)
Timepoint [4] 262318 0
until 24 months after the initiation of the treatment
Secondary outcome [5] 262319 0
adverse effects, such as liver injury, deterioration of renal function, and abnormalities of peripheral blood cell counts by questionnaries and medical examinations
Timepoint [5] 262319 0
until 24 months after the initiation of the treatment

Eligibility
Key inclusion criteria
Biopsy proven idiopathic membranous nephropathy.

Over 3.5 g/day of excretion of urinary protein.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Secondary forms of membranous nephropathy.
Less than 70 ml/min of creatinine clearance.
Patients with relapse or recurrence.
Treated with other immunosuppressants.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2128 0
Japan
State/province [1] 2128 0
Ibaraki

Funding & Sponsors
Funding source category [1] 244040 0
Charities/Societies/Foundations
Name [1] 244040 0
Research Group for Treatments of Kidney Diseases in Ibaraki, Japan
Country [1] 244040 0
Japan
Primary sponsor type
Charities/Societies/Foundations
Name
Research Group for Treatments of Kidney Diseases in Ibaraki, Japan
Address
Research Group for Treatments of Kidney Diseases in Ibaraki, University of Tsukuba, 1-1-1 Ten-nodai, Tsukuba, Ibaraki 305-8575
Country
Japan
Secondary sponsor category [1] 251386 0
None
Name [1] 251386 0
Address [1] 251386 0
Country [1] 251386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258136 0
Ethics committee of Tokyo Medical Univsersity Ibaraki Medical Center
Ethics committee address [1] 258136 0
3-20-1 Chuo, Ami, Ibaraki 300-0395
Ethics committee country [1] 258136 0
Japan
Date submitted for ethics approval [1] 258136 0
Approval date [1] 258136 0
Ethics approval number [1] 258136 0

Summary
Brief summary
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30261 0
Address 30261 0
Country 30261 0
Phone 30261 0
Fax 30261 0
Email 30261 0
Contact person for public queries
Name 13508 0
Dr, Kouichi, Hirayama
Address 13508 0
Associate professor, Department of Nephrology, Tokyo Medical University Ibaraki Medical Center, 3-20-1 Chuo, Ami, Inashiki, Ibaraki 300-0395
Country 13508 0
Japan
Phone 13508 0
+81 29 887 1161
Fax 13508 0
+81 29 887 6266
Email 13508 0
k-hira@tokyo-med.ac.jp
Contact person for scientific queries
Name 4436 0
Dr, Akio, Koyama
Address 4436 0
President, , Ibaraki Prefectural University of Health Science, 4669-2 Ami, Ami, Inashiki, Ibaraki 300-0394
Country 4436 0
Japan
Phone 4436 0
+81 29 888 4000
Fax 4436 0
Email 4436 0
koyama@ipu.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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.