UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002002
Receipt number R000002439
Scientific Title Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD).
Date of disclosure of the study information 2009/05/25
Last modified on 2014/05/24 13:43:44

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Basic information

Public title

Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD).

Acronym

STudy Of hyperPhosphatemia in CKD5D patients undergoing HemoDialysis (STOP-HD).

Scientific Title

Prospective Study of hyperphosphatemia in CKD5D patients undergoing hemodialysis (STOP-HD).

Scientific Title:Acronym

STudy Of hyperPhosphatemia in CKD5D patients undergoing HemoDialysis (STOP-HD).

Region

Japan


Condition

Condition

Hemodialysis patients with hyperphosphatemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

#Evaluate the treatment trend of La carbonate for CKD5D patients with hyperphospatemia
#Assess the influence of the aortic calcification index (ACI) after Lanthanum carbonate treatment on prognostic events

Basic objectives2

Others

Basic objectives -Others

Relationship between clinical course and time dependent change/prognosis of (aortic calcification index) ACI score.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

#Treatment status of phosphate binders and VitaminD
#Measure aortic calcification (ACI) at baseline and after the treatment of La carbonate (maximum 5 years).

Key secondary outcomes

P,Ca, intact-PTH, Alb, Lipid, CRP, hepatic function, CTR, nPCR, vital sign, safety and tolerability at baseline and after the treatment of La carbonate (maximum 5 years).


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

Lanthanum carbonate 250-750mg will be administered orally three times daily after meals for 5 years.

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) CKD5D patients undergoing HemoDialysis, Age >=20
2) Patients who can receive La carbonate treatment
3) Patients who undergo hemodialysis between 3 months and 10 years
4) Possible long term observation patients
5) Patients with written IC (Informed Consent)

Key exclusion criteria

1) Patients with cancer or suspicious for cancer
2) Pregnant or possibly pregnant patients, patients on lactation
3) Patients who meet the contraindiation criteria in package insert of Lanthanum carbonate
4) Inappropriate patients for this study according to the investigator's judgment

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Professor Takashi Shigematsu

Organization

Wakayama Medical University

Division name

Division of Nephrology & Blood Purification Medicine

Zip code


Address

811-1, Kimiidera, Wakayama city, 641-8510, Wakayama, Japan

TEL

073-447-2300

Email



Public contact

Name of contact person

1st name
Middle name
Last name Associate Professor, Shigeo Negi

Organization

Wakayama Medical University

Division name

Division of Nephrology & Blood Purification Medicine

Zip code


Address

811-1, Kimiidera, Wakayama city, 641-8510, Wakayama, Japan

TEL


Homepage URL


Email

shigeon@wakayama-med.ac.jp


Sponsor or person

Institute

Phosphate Research group

Institute

Department

Personal name



Funding Source

Organization

The Waksman foundation of Japan inc.

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


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

2009 Year 05 Month 25 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

Completed

Date of protocol fixation

2009 Year 05 Month 20 Day

Date of IRB


Anticipated trial start date

2009 Year 06 Month 01 Day

Last follow-up date

2015 Year 05 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2015 Year 12 Month 01 Day

Date analysis concluded

2016 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 05 Month 24 Day

Last modified on

2014 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002439


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name