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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011292
Receipt No. R000013229
Scientific Title Penetration of meropenem into cysts in patients with autosomal dominant polycystic kidney disease (ADPKD).
Date of disclosure of the study information 2013/07/26
Last modified on 2014/02/24

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Basic information
Public title Penetration of meropenem into cysts in patients with autosomal dominant polycystic kidney disease (ADPKD).
Acronym Intracystic penetration of MEPM in ADPKD.
Scientific Title Penetration of meropenem into cysts in patients with autosomal dominant polycystic kidney disease (ADPKD).
Scientific Title:Acronym Intracystic penetration of MEPM in ADPKD.
Region
Japan

Condition
Condition Renal or hepatic cyst infection in patients with autosomal dominant polycystic kidney disease (ADPKD).
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the profile of the cyst fluid concentration of meropenem (MEPM) in ADPKD patients receiving intravenous MEPM for infected cysts.
Basic objectives2 Others
Basic objectives -Others To investigate correlations between the serum and cyst fluid concentration of MEPM and various clinical features, such as the age, sex, body weight, renal function, liver function, renal volume, liver volume, and serum albumin level.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum and cyst fluid concentrations of MEPM.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All ADPKD patients who are treated with intravenous MEPM and cyst drainage for infected cysts in Toranomon Hospital from August 2013.
Key exclusion criteria Patients who do not agree to participate in this study will be excluded.
Target sample size 10

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoshifumi Ubara
Organization Toranomon Hospital Kajigaya
Division name Department of Nephrology
Zip code
Address 1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa 213-8587
TEL +81-44-877-5111
Email suwabe@toranomon.gr.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tatsuya Suwabe, Satoshi Hamanoue
Organization Toranomon Hospital Kajigaya
Division name Department of Nephrology
Zip code
Address 1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa 213-8587
TEL +81-44-877-5111
Homepage URL
Email suwabe@toranomon.gr.jp

Sponsor
Institute Department of Nephrology, Toranomon Hospital Kajigaya
Institute
Department

Funding Source
Organization Department of Nephrology, Toranomon Hospital Kajigaya
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts
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 虎の門病院分院 (Toranomon Hospital Kajigaya)
同志社女子大学薬学部 臨床薬剤学 (Department of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Open public recruiting
Date of protocol fixation
2013 Year 07 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cyst infection is a frequent and serious complication of autosomal dominant polycystic kidney disease (ADPKD) that is often difficult to treat and can be fatal. Water-soluble antibiotics do not penetrate inside cysts well, while lipid-soluble antibiotics show good penetration into cysts and these antibiotics are recommended for treating cyst infection in ADPKD patients. However, we sometimes encounter cyst infection that is resistant to lipid-soluble antibiotics like fluoroquinolones or trimethoprim-sulfamethoxazole, and we sometimes have to use carbapenems such as MEPM in ADPKD patients who have antibiotic-resistant cyst infection. Carbapenems are water-soluble antibiotics and there has never been an investigation of their intracystic penetration in ADPKD patients. Therefore, we decided to investigate the intracystic penetration of MEPM in ADPKD patients with cyst infection. The choice of MEPM for treatment and the performance of cyst drainage will be decided by the attending physician, but MEPM and drainage are generally only employed for refractory cyst infection. This will be an observational prospective study that does not influence the treatment of each patient.


Management information
Registered date
2013 Year 07 Month 26 Day
Last modified on
2014 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013229

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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