UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective analysis of long term lanthanum carbonate therapy
Acronym	Long Term LAnthanum Carbonate Therapy (Lot-LACT)
Scientific Title	Retrospective analysis of long term lanthanum carbonate therapy
Scientific Title:Acronym	Long Term LAnthanum Carbonate Therapy (Lot-LACT)
Region	Japan

Condition
Condition	End stage renal disease undergoing hemodialysis treatment
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate long-term safety in the patients who completed the three year clinical study of lanthanum carbonate
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Adverse event
Key secondary outcomes	Therapeutic effect on hyperphosphatemia

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who completed the long-term clinical study of lanthanum carbonate (3 years). The patients of filling the following all criteria and having ability for agreement
Key exclusion criteria	The patients who did not complet the long-term clinical study of lanthanum carbonate (3 years). The patients without agreement
Target sample size	34

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Shigematsu
Organization	Wakayama Medical University
Division name	Division of Nephrology
Zip code
Address	811-1, Kimiidera Wakayama city, Wakayama
TEL	+81-73-441-0638
Email	taki@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shigeo Negi
Organization	Wakayama Medical University
Division name	Division of Nephrology
Zip code
Address	811-1, Kimiidera Wakayama city, Wakayama
TEL	+81-73-441-0639
Homepage URL
Email	shigeon@wakayama-med.ac.jp

Sponsor
Institute	Division of Nephrology, Wakayama Medical University, Japan
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2014 Year 09 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	8 years of lanthanum carbonate observational study reveals the safety in Japanese hemodialysis patients.
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	2014 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date	2014 Year 09 Month 25 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	published Shigematsu et al. Renal Replacement Therapy (2016) 2:30 DOI 10.1186/s41100-016-0040-4

Management information
Registered date	2014 Year 09 Month 23 Day
Last modified on	2016 Year 09 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017704

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