Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
JPRN |
Last refreshed on:
|
17 October 2023 |
Main ID: |
JPRN-C000000369 |
Date of registration:
|
27/03/2006 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome
|
Scientific title:
|
Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome - Combine therapy of prednisolone and cyclosporin in refractory nephrotic syndrome |
Date of first enrolment:
|
2004/04/01 |
Target sample size:
|
300 |
Recruitment status: |
Complete: follow-up complete |
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000463 |
Study type:
|
Interventional |
Study design:
|
Parallel Randomized
|
Phase:
|
Not selected
|
|
Countries of recruitment
|
Japan
| | | | | | | |
Contacts
|
Name:
|
Takao Saito |
Address:
|
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
Japan |
Telephone:
|
092-801-1011 |
Email:
|
tsaito@fukuoka-u.ac.jp |
Affiliation:
|
Project team for treatment of refractory nephrotic syndrome Division of Nephrology and Rheumatology, Department of Internal Medicine, Fukuoka University School of Medicine |
|
Name:
|
Takao Saito |
Address:
|
7-45-1 Nanakuma, Jonan-ku, Fukuoka
Japan |
Telephone:
|
092-801-1011ext.3374 |
Email:
|
tsaito@fukuoka-u.ac.jp |
Affiliation:
|
Project team for refractory nephrotic syndrome Division of Nephrology and Rheumatology, Fukuoka University Hospital |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: 1) The subject presents with renal dysfunction (Ccr less than 50mL/min or serum creatinine more than 2mg/dL). 2) The subject has been treated with other immunosuppressants within one month prior to the study commencement. 3) The subject should be treated with nephrotoxic or hyperkalemic agents during the study period. 4) The subject has a malignant tumor, or had a recurrent malignant tumor previously. 5) The subject has hypertension uncontrolled with antihypertensive drugs. 6) The subject has malabsorption syndrome, cerebral dysfunction or epilepsy. 7) The subject has hyperkalemia or hyperuricemia. 8) The subject has a severe cardiac, hepatic or pancreatic disease. 9) The subject is currently pregnant, is supposed to be pregnant, or is nursing. 10) The subject has an infectious complication and is not available for the treatment with Immunosuppressants. 11) The subject previously had hypersensitivity to CyA-MEPC. 12) The subject is inappropriate for participation in the study as determined by an investigator.
Age minimum:
16years-old
Age maximum:
75years-old
Gender:
Male and Female
|
Health Condition(s) or Problem(s) studied
|
membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome
|
Intervention(s)
|
CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks
|
Primary Outcome(s)
|
urine protein excretion (g/day) remission status of nephrotic syndrome
|
Secondary Outcome(s)
|
renal function(creatinine clearance(Ccr)) serum total protein and albumin levels serum total cholesterol level
|
Source(s) of Monetary Support
|
Japan Kidney Foundation
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|