Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome

• 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
• Affiliation: Project team for refractory nephrotic syndrome Division of Nephrology and Rheumatology, Fukuoka University Hospital

• Name: Takao Saito
• Affiliation: Project team for treatment of refractory nephrotic syndrome Division of Nephrology and Rheumatology, Department of Internal Medicine, Fukuoka University School of Medicine

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

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 Completed: 01/12/2008
• URL: http://link.springer.com/article/10.1007/s10157-013-0925-2/fulltext.html