UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001852 |
|---|---|
| Receipt number | R000002225 |
| Scientific Title | Combination Therapy of Lanthanum Carbonate and Calcium Carbonate: COLC Study |
| Date of disclosure of the study information | 2009/04/06 |
| Last modified on | 2014/09/23 10:18:00 |
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Basic information
Public title
Combination Therapy of Lanthanum Carbonate and Calcium Carbonate: COLC Study
Acronym
Combination Therapy of Lanthanum Carbonate and Calcium Carbonate: COLC Study
Scientific Title
Combination Therapy of Lanthanum Carbonate and Calcium Carbonate: COLC Study
Scientific Title:Acronym
Combination Therapy of Lanthanum Carbonate and Calcium Carbonate: COLC Study
Region
| Japan |
Condition
Condition
Hemodialysis patients with hyperphosphatemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy of La carbonate add on therapy in Ca carbonate-failure HD patients with hyperphosphatemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
To evaluate the target achievement rate of P<=6.0 mg/dL under combination therapy with Ca carbonate and La carbonate
Key secondary outcomes
P, Ca, CaxP product, intact-PTH, CRP, Nutrition Index (albumin, nPCR), Bone metabolism marker (ALP, BAP, TRAP5b), P regulating factor (FGF-23), Safety and tolerability at baseline, 4, 8, 12 and 16 week aftrer combination with Ca carbonate and La carbonate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Each subject will orally receive Ca carbonate (continue dosage of a baseline) three times daily after meals for 16 weeks. Lanthanum carbonate 250-750mg will also be administered orally three times daily after meals for 16 weeks.
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
1) Hemodialysis patients
2) Duration of hemodialysis more than three month
3) Age >20
4) Serum P > 6.0mg/dL
5) Who takes Ca carbonate
6) Pts with written Informed Consent
Key exclusion criteria
1) Pts with cancer or suspicious for cancer
2) Pregnant or possibly pregnant pts, pts on lactation
3) Pts who have obvious gastrointestinal disease(active peptic ulcer, ulcerative colitis, crohn disease, intestinal stenosis)
4) Pts who have severe hepatic dysfunction
Pts who are treated with Sevelamer (terminate Sevelamer before 3 wks
Inappropriate pts for this study according to the investigator's judgment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Shigematsu MD, PhD |
Organization
Wakayama Medical University
Division name
Division of Nephrology & Blood Purification Medicine
Zip code
Address
811-1, Kimiidera, Wakayama city
TEL
073-447-2300
taki@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeo Negi MD, PhD |
Organization
Wakayama Medical University
Division name
Division of Nephrology & Blood Purification Medicine
Zip code
Address
811-1, Kimiidera, Wakayama city
TEL
073-447-2300
Homepage URL
shigeon@wakayama-med.ac.jp
Sponsor or person
Institute
COLC Study Research group
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2009 | Year | 04 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/21771755
Number of participants that the trial has enrolled
Results
Nephrol Dial Transplant. 2011 Jul 19. [Epub ahead of print]
Combined therapy with lanthanum carbonate and calcium carbonate for hyperphosphatemia decreases serum FGF-23 level independently of calcium and PTH (COLC Study).
Shigematsu T, Negi S; and the COLC Research Group.
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
| 2009 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 06 | Day |
Last modified on
| 2014 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002225
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
