UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053361 |
|---|---|
| Receipt number | R000060741 |
| Scientific Title | A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients. |
| Date of disclosure of the study information | 2024/01/17 |
| Last modified on | 2025/07/18 12:25:35 |
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Basic information
Public title
A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients.
Acronym
A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients.
Scientific Title
A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients.
Scientific Title:Acronym
A randomized controlled non-blinded trial for examination of effectiveness of Upacicalcet and Etelcalcetide on hyperparathyroidism in hemodialysis patients.
Region
| Japan |
Condition
Condition
Secondary hyperparathyroidism in hemodialysis patients
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Optimal Clinical Potency of Upacalcet and Etelcalcetide in Hemodialysis Patients with Secondary Hyperparathyroidism, Including Concomitant Medications
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weekly doses of vitamin D preparations every 4 weeks after the start of calcimimetics administration and the change from the start of calcimimetics administration.
Key secondary outcomes
Percentage of patients achieving management targets for corrected Ca, P, and intact PTH every 4 weeks after initiation of treatment.
Time to achieve pre-dialysis serum intact PTH concentrations of 60-240 pg/mL, the control target.
Percentage of patients with intact PTH 30% reduction every 4 weeks after initiation of treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group U: Upacicarsetona sodium hydrate
(Sanwa Kagaku Kenkyusho Co., Ltd. and Kissei Pharmaceutical Industry Co. Product name: Upasita for Intravenous Dialysis)
Injected three times a week into the venous side of the dialysis circuit at the time of blood return at the end of dialysis.
<Starting dose> 25 mcg per dose for pre-dialysis serum intact PTH greater than 121 pg/mL and pre-dialysis serum corrected calcium concentration less than 9.0 mg/dL; 50 mcg per dose for pre-dialysis serum intact PTH greater than 121 pg/mL and pre-dialysis serum corrected calcium concentration greater than 9.0 mg/dL.
<Dose adjustment criteria>
<Dose escalation>
If pre-dialysis serum intact PTH is greater than 241 pg/mL, the dose should be increased by 1 step starting from the day after the maximum dialysis interval based on the following
1) Current dose has been maintained for at least 3 weeks by the time of dose escalation
2) Pre-dialysis serum corrected calcium concentration of 8.4 mg/dL or greater at the most recent dose increase
3) The investigator determines that there are no safety issues regarding dose escalation
<Dose Reduction>
If pre-dialysis serum intact PTH is less than 60 pg/mL, the dose should be reduced by 1 step from the next dose according to the following
1) If the pre-dialysis serum intact PTH concentration is less than 60 pg/mL for 2 consecutive weeks
(2) When the investigator determines that a dose reduction is necessary
<Withdrawal and Resumption of Dose>
Drug should be stopped immediately in any of the following cases
(1) Serum-corrected calcium concentration becomes less than 7.5 mg/dL
(2) When the investigator determines that a dose reduction is necessary
The drug should be withdrawn until the serum-corrected calcium concentration reaches 8.4 mg/dL or higher, and resumed at the dose before withdrawal or at a dose reduced by one step.
<Combination therapy>
1) Active vitamin D preparation
2) Phosphorus adsorbent
Interventions/Control_2
Group E: Etelcalcetide hydrochloride (Ono Pharmaceutical Co., Ltd., Product name: Parsabiv for intravenous dialysis) injected three times a week into the venous side of the dialysis circuit during return blood at the end of dialysis.
<Starting dose> 5.0 mg once. The dose is adjusted based on pre-dialysis serum intact PTH measured every 2-4 weeks.
<Dose adjustment criteria>
<Dose escalation>
If pre-dialysis serum intact PTH is greater than 241 pg/mL, the dose should be increased by 1 step starting from the day after the maximum dialysis interval based on the following
1) Current dose has been maintained for at least 3 weeks by the time of dose escalation
2) Pre-dialysis serum corrected calcium concentration of 8.4 mg/dL or greater at the most recent dose increase
3) The investigator determines that there are no safety issues regarding dose escalation
<Dose Reduction>
If pre-dialysis serum intact PTH is less than 60 pg/mL, the dose should be reduced by 1 step from the next dose according to the following
1) If the pre-dialysis serum intact PTH concentration is less than 60 pg/mL for 2 consecutive weeks
(2) When the investigator determines that a dose reduction is necessary
<Withdrawal and Resumption of Dose>
Drug should be stopped immediately in any of the following cases
(1) Serum-corrected calcium concentration becomes less than 7.5 mg/dL
(2) When the investigator determines that a dose reduction is necessary
The drug should be withdrawn until the serum-corrected calcium concentration reaches 8.4 mg/dL or higher, and resumed at the dose before withdrawal or at a dose reduced by one step.
<Combination therapy>
1) Active vitamin D preparation
2) Phosphorus adsorbent
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have given written consent to participate in the study.
(2) Men and women at least 18 years of age at the time of consent.
(3) Patients undergoing hemodialysis or hemodiafiltration three times a week on the day of the screening test conducted between 4 weeks and 1 week before the start of treatment.
(4) Patients with pre-dialysis serum intact PTH greater than 121 pg/mL and pre-dialysis serum corrected calcium concentration greater than 8.4 mg/dL after the maximum dialysis day interval at the time of the screening test.
Key exclusion criteria
(1) Patients with primary hyperparathyroidism.
(2) Patients with pre-dialysis serum intact PTH less than 121 pg/mL and pre-dialysis serum corrected calcium concentration less than 8.4 mg/dL after the maximum dialysis day interval at the time of screening after 8 weeks of withdrawal period established after the screening test.
(3) Who has changed the dosage or administration of calcimimetics within 4 weeks before the screening test (including new dosage)
(4) Who is using or has used the following drugs within the respective periods before the screening test
Within 4 weeks: Parathyroid hormone preparations, calcium-containing phosphorus adsorbents
Within 12 weeks: Bisphosphonates
Within 24 weeks: RANKL inhibitors
(5) Who used parathyroid hormone, bisphosphonate, and RANKL inhibitors
(6) Patients with a new history of any of the following within 12 weeks before screening. Parathyroid intervention, bone fracture, myocardial infarction, stroke, lower limb amputation, coronary artery or lower limb revascularization, respiratory failure with resting SpO2 < 90%.
(7) Critically ill patients who are judged to have a life expectancy of 1 year or less.
(8) Patients with malignant tumors, were diagnosed within the past 5 years at the time of obtaining consent.
(9) Granulomatous disease
(10) Liver dysfunction
(11) Patients on peritoneal dialysis (including combined use with hemodialysis).
(12) Pregnant women, lactating women, or women who wish to become pregnant within one year.
(13) With allergy to upacalcet and etelcalcetide.
(14) Who has changed the dialysis method, dialyzer, dialysate, dialysis time, blood flow rate, or dialysate flow rate within 2 weeks before the screening test
(15) Patient on dialysate with a dialysate calcium concentration of less than 2.5 mEq/L
(16) With a history or family history of congenital QT prolongation syndrome.
(17) Who is considered inappropriate for inclusion in the study by the principal investigator
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yuuta |
| Middle name | |
| Last name | Hara |
Organization
Social medical corporation Kenwakai, Kenwakai Hospital.
Division name
Nephrology
Zip code
395-8522
Address
1936 Nakadaira, Iida City, Nagano Prefecture, Japan.
TEL
0265233116
y-hara@kenwakai.or.jp
Public contact
Name of contact person
| 1st name | Yuuta |
| Middle name | |
| Last name | Hara |
Organization
Social medical corporation Kenwakai, Kenwakai Hospital.
Division name
Nephrology
Zip code
395-8522
Address
1936 Nakadaira, Iida City, Nagano Prefecture, Japan.
TEL
0265233116
Homepage URL
y-hara@kenwakai.or.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Yuuta Hara
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social medical corporation Kenwakai, Kenwakai Hospital.
Address
1936 Nakadaira, Iida City, Nagano Prefecture, Japan.
Tel
0265233115
y-hara@kenwakai.or.jp
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
| 2024 | Year | 01 | Month | 17 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060741
