Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis

NCT01872026 | Completed Phase 1

• 1 other identifier: 7991-CL-1003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after oral administration to patients with chronic kidney disease undergoing hemodialysis.

Conditions

Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy; Pharmacodynamics of ASP7991; Pharmacokinetics of ASP7991

Keywords

ASP7991; Plasma concentration; Pharmacodynamics; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs, ECGs for QT evaluation and ophthalmic examination

  For 9-16 days after dosing

Secondary Outcomes (2)

• Plasma concentrations unchanged drug; AUClast, AUCinf, AUC24h, Cmax, Ctrough, tmax, t1/2, CL/F, Vz/F

  For 9-16 days after dosing

• iPTH, wPTH, corrected serum Ca* (Serum Ca and Serum Alb), P

  For 9-16 days after dosing

Study Arms (2)

Part 1- single administration

EXPERIMENTAL

The lowest, middle and the highest dose ASP7991 as a single oral administration on non-dialysis day in step 1 to 3 and the highest dose on day of dialysis in step 4.

Drug: ASP7991

Part 2- repeated administration

EXPERIMENTAL

The lowest, middle and the highest dose ASP7991 as repeated oral administration in step 1 to 3.

Drug: ASP7991

Interventions

ASP7991 DRUG

oral

Part 1- single administration; Part 2- repeated administration

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on stable chronic maintenance dialysis who are receiving hemodialysis therapy 3 times/week for more than 12 weeks (84 days) and are also scheduled to undergo the regimen of 3 times/week hemodialysis during the study period
• Patients who have secondary hyperparathyroidism;
• Receiving Active vitamin D or Cinacalcet hydrochloride
• OR iPTH values ≥ 180 pg/mL at screening in case patients receive no medication for secondary hyperparathyroidism.
• Corrected serum Ca at screening：≥ 8.4 mg/dL
• No changes in items below at least 7 days before screening and do not have a plan to change something in the items below during the trial.
• Dose and type of Active Vitamin D, Calcitonin preparation, Phosphate binder.
• Ca concentration of the dialysate, membrane area of the dialyzer and dialysis time of each week(possible to change within ±10%)

You may not qualify if:

• Patients who underwent parathyroid intervention within 24 weeks prior to the informed consent
• Patients who have primary hyperparathyroidism
• Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract
• Patients with uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and diastolic blood pressure ≥ 120 mmHg are showed at the previous three points at the initiation of dialysis including the screening assessment)
• 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 obtaining the informed consent.
• Concurrent serious hepatic disease (acute and active chronic hepatitis, hepatic cirrhosis)
• History of malignant tumor
• History of serious drug allergy including anaphylactic shock
• Potentially child-bearing, lactating, those who do not comply with the instructed contraceptive measures
• Patients who were involved in an assessment of other clinical trial within 12 weeks(84 days) prior to the informed consent
• Patients who is an employee of the sponsor, CRO, SMO, or sites related to the study.
• Patients who have been judged ineligible to participate in the study by the investigator / sub investigator.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Unknown Facility

Kantou, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Interventions

ASP7991

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: December 26, 2012
• Primary Completion: June 26, 2013
• Study Completion: June 26, 2013
• Last Updated: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)