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UMIN-CTR Clinical Trial |
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Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000015227 |
Receipt No. | R000017704 |
Scientific Title | Retrospective analysis of long term lanthanum carbonate therapy |
Date of disclosure of the study information | 2014/09/25 |
Last modified on | 2016/09/25 |
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 |
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Condition | ||
Condition | End stage renal disease undergoing hemodialysis treatment | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | The patients who did not complet the long-term clinical study of lanthanum carbonate (3 years).
The patients without agreement |
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Target sample size | 34 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Wakayama Medical University | ||||||
Division name | Division of Nephrology | ||||||
Zip code | |||||||
Address | 811-1, Kimiidera Wakayama city, Wakayama | ||||||
TEL | +81-73-441-0638 | ||||||
taki@wakayama-med.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017704 |