UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Serum and cyst fluid concentrations of MEPM.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Nephrology, Toranomon Hospital Kajigaya

Institute

Department

Personal name

Organization

Department of Nephrology, Toranomon Hospital Kajigaya

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Department of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Doshisha Women's College of Liberal Arts

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2013

Year

07

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2013

Year

07

Month

26

Day

Last modified on

2014

Year

02

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013229