A Study to Evaluate the Effect of ASP7991 in Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

NCT02133404 | Completed Phase 2

• 1 other identifier: 7991-CL-1004
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 6

Brief Summary

To examine efficacy and safety after 12-week administration of ASP7991 in secondary hyperparathyroidism patients undergoing hemodialysis

Conditions

Secondary Hyperparathyroidism

Keywords

Mineral bone disease(MBD); Chronic kidney disease(CKD); secondary hyperparathyroidism(SHPT)

Outcome Measures

Primary Outcomes (1)

• Serum iPTH concentration

  iPTH: intact parathyroid hormone

  Before and at 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment

Secondary Outcomes (6)

• Corrected serum Ca, Phosphate(P) concentration

  Before and at 3, 8, 15, 22, 24, 29, 36, 43, 45, 50, 57, 64, 66, 71, 78, 85 and 92 days after start of the treatment

• serum vitamin D concentration

  Before and at 22, 43, 64, 85 and 92 days after start of the treatment

• serum wPTH concentration

  Before and at 22, 43, 64, 85 and 92 days after start of the treatment

• Serum concentration of bone metabolism markers

  Before and at 22, 43, 64, 85 and 92 days after start of the treatment

• Serum FGF23 concentration

  Before and at 22, 43, 64, 85 and 92 days after start of the treatment

Study Arms (2)

ASP7991 group

EXPERIMENTAL

receiving ASP7991 and Cinacalcet-placebo

Drug: ASP7991; Drug: Placebo

Cinacalcet group

ACTIVE COMPARATOR

receiving Cinacalcet and ASP7991-placebo

Drug: Cinacalcet; Drug: Placebo

Interventions

ASP7991 DRUG

oral

ASP7991 group

Cinacalcet DRUG

oral

Cinacalcet group

Placebo DRUG

oral

ASP7991 group; Cinacalcet group

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week since before 12-week (84 days) administration and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period
• Patients with secondary hyperparathyroidism
• Patients whose serum iPTH concentration is \>240 pg/mL and corrected serum Ca is ≥ 9.0 mg/dL
• Patients who have had no changes in the following items ≥4-week (28 days).
• Dosage and regimen, including new administration, of active vitamin D, calcitonin preparation, phosphate binder, and medication with phosphate absorption (including foods)
• Ca concentration of the dialysate, membrane area of the dialyzer, and dialysis time of each week

You may not qualify if:

• Patients who underwent parathyroid intervention, such as parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT), within 24 weeks (168 days) prior to the administration
• Patients who have primary hyperparathyroidism
• Patients who received bisphosphonate, estrogen preparation, parathyroid hormone within 4 weeks (28 days)
• Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are observed at \>2/3 of all confirmable measurements
• Patients who are complicated by severe heart disorder \[congestive cardiac failure (NYHA classification III or higher), or wide range of old myocardial infarction\], or having a history of hospitalization for cerebro-vascular disease or heart disorder within 12 weeks (84 days) before administration of the study drug
• Patients with hepatic function abnormal (ALT or AST is \>2× ULN, or total bilirubin (T-bil) is \> 1.5 × ULN.)
• Patients with a history of malignant tumor or the patient's condition is complicated by malignant tumor. (However, enrollment is acceptable if the tumor has not relapsed for 5 years or longer.)
• Patients with a history of serious drug allergy including anaphylactic shock
• Patients with a history of drug allergy to Cinacalcet hydrochloride
• Female patients who are potentially child-bearing or lactating, or patients who do not comply with the instructed contraceptive measures
• Patients who were or are currently involved in trials for other investigational drugs or medical devices, or clinical trial for post-marketing study drugs within 12 weeks (84 days) before the study
• Patients who have received ASP7991 in the past
• Patients who were judged ineligible to participate in the study by the
• investigator / subinvestigator

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (6)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results Web site

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic

Interventions

ASP7991; Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 8, 2014
• Study Start: March 14, 2014
• Primary Completion: November 10, 2014
• Study Completion: November 10, 2014
• Last Updated: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (6)