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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000004212 |
Receipt No. | R000005061 |
Scientific Title | The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia |
Date of disclosure of the study information | 2010/10/01 |
Last modified on | 2015/01/05 |
Basic information | ||
Public title | The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia | |
Acronym | REG study | |
Scientific Title | The effects of cinacalcet hydrochloride on the regression of the parathryoid gland hyperplasia | |
Scientific Title:Acronym | REG study | |
Region |
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Condition | ||
Condition | Secondary hyperparathyroidism under hemodialysis therapy | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the clinical effects of cinacalcet on the parathyroid gland volume in patients with moderate to advanced secondary hyperparathyroidism |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | The changes in parathyroid gland volume after cinacalcet hydrochloride treatment |
Key secondary outcomes | Serial changes in the serum levels of intact PTH, corrected calcium, phosphorus and alkaline phosphatase, and in the doses of drugs used for secondary hyperparathyroidism |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Historical |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Administration of cinacalcet hydrochloride to hemodialysis patients with moderate to advanced secondary hyperparathyroidism | |
Interventions/Control_2 | ||
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | 1)Patients with a history of more than 6 months of hemodialysis therapy, 2) patients with secondary hyperparathyroidism refractory to conventional medical treatment, 3) patients with serum intact PTH of more than 180 pg/ml and serum corrected calcium of more than 9mg/dl, 4) patiens who newly start to recieve cinacalcet treatment | |||
Key exclusion criteria | Patients who have a past history of surgical parathyroidectomy and percutaneous ethanol injection therapy are excluded. In addition, patients who have been suffered from lifethreatening medical conditios such as malignancy or severe infection. | |||
Target sample size | 80 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu University | ||||||
Division name | Department of Chronic Kidney Disease, Graduate School of Medical Science | ||||||
Zip code | |||||||
Address | 3-1-1Maidashi, Higashi-ku, Fukuoka, Japan | ||||||
TEL | 092-642-5843 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Kyusuhu University | ||||||
Division name | Department of Medicien and Clinical Science | ||||||
Zip code | |||||||
Address | 3-1-1Maidashi, Higashi-ku, Fukuoka, Japan | ||||||
TEL | 092-642-5843 | ||||||
Homepage URL | |||||||
masatomo@kcu.med.kyushu-u.ac.jp |
Sponsor | |
Institute | Department of Chronic Kidney Disease, Graduate School of Medical Science, Kyushu University |
Institute | |
Department |
Funding Source | |
Organization | Department of Medicine and Clinical Sicence, Graduate School of Medical Sciences, Kyushu University |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Fukuoka Renal Clinic |
Name of secondary funder(s) |
IRB Contact (For public release) | |
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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 | 九州大学病院(福岡県) |
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 | Two years of treatment with cinacalcet hydrochloride significantly decreased parathryoid gland volumes, independent of the baseline PTH values and parathyroid gland volumes in 60 hemodialysis patients with secondary hyperparathyroidism. During the treatment period, serum PTH valuse increased in some patients, indicating that some patients showed resistance to cinacalcet treatment. |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005061 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |