UMIN-CTR Clinical Trial

Public title

Exploration of optimal parathyroid hormone concentrations on markers of chronic kidney disease - mineral and bone disorders (CKD-MBD) in hemodialysis patients.

Acronym

Undergoing hemodialysis Trial Of PTH-lowering therapy In pAtients with CKD-MBD (SK-2023)

Scientific Title

Exploration of optimal parathyroid hormone concentrations on markers of chronic kidney disease - mineral and bone disorders (CKD-MBD) in hemodialysis patients.

Scientific Title:Acronym

UTOPIA (SK-2023)

Region

Japan

Condition

chronic kidney disease-mineral and bone disorders (CKD-MBD) in hemodialysis patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The 2012 "Guidelines for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients" by the Japan Society for Dialysis Therapy states that iPTH should be controlled between 60 pg/mL and 240 pg/mL, but recent study has shown that hemodialysis patients with secondary hyperparathyroidism who had a parathyroidectomy (PTx) had a lower risk of all-cause mortality and cardiovascular mortality compared with those who did not undergo PTx.. Therefore, we believe it is necessary to reexamine the optimal PTH range. We would like to divide patients into two groups: Group A, in which iPTH is controlled within the range of 60 pg/mL to 120 pg/mL, and Group B, in which iPTH is controlled within the range of 180 pg/mL to 240 pg/mL, within the current guidelines, and evaluate the percentage of patients in each group achieving the target control of serum P and Ca concentration after one year.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Percentage of serum P and Ca concentrations achieving control targets at the end of treatment (52 weeks)

Key secondary outcomes

1) Amount and rate of change in bone mineral density (DXA method, lumbar vertebrae and femur) before and after administration
2) Intact PTH, P, Ca, Ca x P product at baseline and 13, 26, and 52 weeks, bone metabolism markers (P1NP, BAP, TRACP-5b) at baseline and 26 and 52 weeks, intact FGF23, 25-OH vitamin D, BNP, heart echo, CAVI, ABI, TBI

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A: iPTH control target within current guidelines, within the range of iPTH 60 pg/mL to 120 pg/mL using Upacicalcet

Interventions/Control_2

Group B: iPTH management target within current guidelines, with iPTH between 180 pg/mL and 240 pg/mL using Upacicalcet

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

18

years-old

<=

Age-upper limit

86

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Maintenance hemodialysis patients who have been receiving hemodialysis 3 times a week for at least 3 months after induction of hemodialysis
2) Male and female patients aged between 18 and 86 years old at the time of consent
3) Serum iPTH level of 240 pg/mL or higher during the observation period
4) Serum corrected Ca level of 8.4 mg/dL or higher at the observation period
5) Research subjects who have given a thorough explanation of their participation in this study and have given their free and voluntary written consent
6) Outpatients

Key exclusion criteria

Patients who have any of the following will not be included in this study
1) Patients with a history of parathyroid intervention or fracture within 12 weeks prior to obtaining consent
2) Patients with myocardial infarction or stroke, or lower extremity amputation, or coronary artery reconstruction or lower extremity revascularization within 12 weeks prior to obtaining consent
3) Patients with heart failure of New York heart association (NYHA) cardiac function class III or higher as of the date of consent
4) Patients with respiratory insufficiency with a resting transcutaneous oxygen saturation of peripheral artery (SpO2) of less than 90% as of the date of consent
5) Critically ill patients whose life expectancy is judged to be within 1 year as of the date of consent
6) Patients with severe liver disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal)
7) Patients with active infections or uncured malignant tumors
8) Patients undergoing concomitant peritoneal dialysis
9) Pregnant women or women of childbearing potential
10) Women who are breast-feeding
11) Patients with allergy to Upacicalcet as of the date of consent
12) Patients who, as of the date of consent, were taking estrogen hormones, synthetic estrogens, selective estrogen receptor modulators, calcitonin, bisphosphonates, anti-RANKL (receptor activator of NF-kB ligand) monoclonal antibodies, anti-Sclerostin antibody, parathyroid hormone preparation (teriparatide), or zoledronic acid hydrate injection.
13) Other patients deemed inappropriate as research subjects by the principal investigator or subinvestigator.

Target sample size

124

Name of lead principal investigator

1st name	Sumi
Middle name
Last name	Hidaka

Organization

Shonan Kamakura General Hospital

Division name

Kideny Disease and Transplant Center

Zip code

247-8533

Address

Okamoto 1370-1, Kamakura, Japan

TEL

0467-46-1717

Email

s_hidaka@shonankamakura.or.jp

Name of contact person

1st name	Sumi
Middle name
Last name	Hidaka

Organization

Shonan Kamakura General Hospital

Division name

Kideny Disease and Transplant Center

Zip code

247-8533

Address

Okamoto 1370-1, Kamakura, Japan

TEL

0467-46-1717

Homepage URL

Email

s_hidaka@shonankamakura.or.jp

Institute

Tokushukai Shonan Kamakura General Hospital (Clinical Research Center)

Institute

Department

Personal name

Organization

Tokushukai Shonan Kamakura General Hospital (Clinical Research Center)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

The Tokushukai Group Ethics Committee

Address

1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan

Tel

03-3263-4801

Email

https://www.mirai-iryo.com/service/ethics_committee/about.php

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

05

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

2023

Year

11

Month

06

Day

Date of IRB

2023

Year

11

Month

10

Day

Anticipated trial start date

2024

Year

04

Month

23

Day

Last follow-up date

2025

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

02

Day

Last modified on

2024

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060120