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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000369
Receipt No. R000000463
Scientific Title Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome
Date of disclosure of the study information 2006/03/27
Last modified on 2014/03/25

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Basic information
Public title Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome
Acronym Combine therapy of prednisolone and cyclosporin in refractory nephrotic syndrome
Scientific Title Multicenter study for combined therapy of prednisolone and cyclosporin in refractory nephrotic syndrome
Scientific Title:Acronym Combine therapy of prednisolone and cyclosporin in refractory nephrotic syndrome
Region
Japan

Condition
Condition membranouos nephropathy and focal segmental glomerulosclerosis with primary steroid resistant nephrotic syndrome
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We prospectively and randomizedly study the best method of combined therapy using cyclosporin emulsion (CyA-MEPC) for primary steroid resistant nephrotic syndrome in adults.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes urine protein excretion (g/day)
remission status of nephrotic syndrome
Key secondary outcomes renal function(creatinine clearance(Ccr))
serum total protein and albumin levels
serum total cholesterol level

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CyA-MEPC once a day per os administration at 3mg/kgBW for 48 weeks
Interventions/Control_2 CyA-MEPC twice a day per os administration at total 3mg/kgBW for 48 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) The subject's urine protein excretion is more than 3.5g/day and serum albumin level is less than 3.0g/dL before the treatment. In addition, corticosteroids treatment for more than 4 weeks has not reduced the subject's urine protein excretion into less than 1g/day before the study commencement.
2) Before registration, membranous nephropathy or focal segmental glomerulosclerosis is diagnosed by renal biopsy.
3) The subject has never been treated with CyA-MEPC before registration.
4) The subject has voluntarily signed a document of the informed consent.
Key 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.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Saito
Organization Project team for treatment of refractory nephrotic syndrome
Division name Division of Nephrology and Rheumatology, Department of Internal Medicine, Fukuoka University School of Medicine
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL 092-801-1011
Email tsaito@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Saito
Organization Project team for refractory nephrotic syndrome
Division name Division of Nephrology and Rheumatology, Fukuoka University Hospital
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL 092-801-1011ext.3374
Homepage URL http://www.wan.jp/mhw/
Email tsaito@fukuoka-u.ac.jp

Sponsor
Institute Project team for treatment of refractory nephrotic syndrome
Institute
Department

Funding Source
Organization Japan Kidney Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor The Progressive Renal Disease Research Projects in the Ministry of Health, Labor and Welfare, Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007/s10157-013-0925-2/fulltext.html
Number of participants that the trial has enrolled
Results
Background
Combined treatment with cyclosporine microemulsion preconcentrate (CyA MEPC) and steroids has been widely used for idiopathic membranous nephropathy (IMN) associated with steroid-resistant nephrotic syndrome (SRNS). Recent studies have shown that once-a-day and preprandial administration of CyA MEPC is more advantageous than the conventional twice-a-day administration in achieving the target blood CyA concentration at 2 h post dose (C2). We designed a randomized trial to compare these administrations.

Methods
IMN patients with SRNS (age 16-75 years) were divided prospectively and randomly into 2 groups. In group 1 (n = 23), 2-3mg/kg body weight (BW) CyA MEPC was given orally once a day before breakfast. In group 2 (n = 25), 1.5 mg/kg BW CyA MEPC was given twice a day before meals. CyA + prednisolone was continued for 48 weeks.

Results
Group 1 showed a significantly higher cumulative complete remission (CR) rate (p = 0.0282), but not when incomplete remission 1 (ICR1; urine protein 0.3-1.0 g/day) was added (p = 0.314). Because a C2 of 600 ng/mL was determined as the best cut-off point, groups 1 and 2 were further divided into subgroups A (C2 >=600 ng/mL) and B (C2 <600 ng/mL). Groups 1A and 2A revealed significantly higher cumulative remission (CR + ICR1) (p = 0.0069) and CR-alone (p = 0.0028) rates. On the other hand, 3 patients with high CyA levels (C2 >900 ng/mL) in Group 1A were withdrawn from the study because of complications.

Conclusion
CyA + prednisolone treatment is effective for IMN with associated SRNS at a C2 >=600 ng/mL. To achieve remission, preprandial once-a-day administration of CyA at 2-3 mg/kg BW may be the most appropriate option. However, we should adjust the dosage of CyA by therapeutic drug monitoring to avoid complications.

 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2004 Year 01 Month 24 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2008 Year 12 Month 01 Day
Date of closure to data entry
2009 Year 01 Month 31 Day
Date trial data considered complete
Date analysis concluded
2013 Year 02 Month 28 Day

Other
Other related information This study was published as below:
Saito T, Iwano M, Matsumoto K, Mitarai T, Yokoyama H, Yorioka N, Nishi S, Yoshimura A, Sato H, Ogahara S, Shuto H, Kataoka Y, Ueda S, Koyama A, Maruyama S, Nangaku M, Imai E, Matsuo S, Tomino Y; The Refractory Nephrotic Syndrome Study Group.
Significance of combined cyclosporine-prednisolone therapy and cyclosporine blood concentration monitoring for idiopathic membranous nephropathy with steroid-resistant nephrotic syndrome: a randomized controlled multicenter trial.
Clin Exp Nephrol. 2013 Dec 23. [Epub ahead of print], Doi10.1007/s10157-013-0925-2(Open choice, free access article)

Management information
Registered date
2006 Year 03 Month 25 Day
Last modified on
2014 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000463

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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