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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: Project team for treatment of refractory nephrotic syndrome
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
Secondary ID(s)
Source(s) of Monetary Support
Japan Kidney Foundation
Secondary Sponsor(s)
The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available: Yes
Date Posted:
Date Completed: 01/12/2008
URL: http://link.springer.com/article/10.1007/s10157-013-0925-2/fulltext.html
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