A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
Primary Purpose
End Stage Renal Disease, Hyperphosphatemia
Status
Unknown status
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
VS-505
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring phosphate binder, dialysis
Eligibility Criteria
Inclusion Criteria:
- Written informed consent given
- Able to comply with the study procedures and medications
- On a stable hemodialysis (HD) regimen (3 times per week) including hemodialysis and hemodiafiltration for ≥12 weeks at screening and during the study period
No change in prescribed dose or frequency of any of the following medications within 4 weeks prior to screening
- Injectable iron agents
- Oral or injectable active vitamin D3
- Oral nutritional vitamin D
- Calcimimetics
- Calcium supplements
- Anti-osteoporotic medication including bisphosphonates
- Calcitonins
- Must be willing to avoid intentional changes in diet throughout the study
- Women of child-bearing potential or non-sterile male subjects and those who are sexually active with a non-sterile female partner must agree to use highly effective contraception
- Plasma Pi level >1.94 mmol/L (6.0 mg/dL) to <3.23 mmol/L (10.0 mg/dL) after 2 weeks washout will qualify patients to enter the treatment period
Exclusion Criteria:
- Blood purification therapy other than HD (hemodialysis and hemodiafiltration)
- The plasma Pi level is >2.26 mmol/L (7.0 mg/dL) within the latest three tests prior to screening.
- Variation of the plasma Pi is over 0.65 mmol/L (2.0 mg/dL) within the latest three tests prior to screening.
- Pre-emptive or scheduled renal transplant
- History of hemochromatosis or ferritin ≥1000 mcg/L
- Oral iron agents including prescribed and over-the-counter drugs at screening.
- Current clinically significant gastrointestinal (GI) disorder, including GI bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, chronic constipation, new diagnosis of peptic or duodenal ulcer disease, within 4 weeks prior to screening
- History of gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening
- Hypertension: Defined using pre-dialysis vital of diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg
- Possible parathyroid intervention including surgical parathyroidectomy and percutaneous ethanol injection therapy during the study period
- Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin
- Severe cardiovascular disorders such as recent myocardial infarction; unstable angina; congested heart failure (NYHA class II or above) hospitalized within 24 weeks (6 months), valve stenosis, atrial fibrillation and arrhythmia
- History of event by cerebrovascular disease or cardiovascular disease within 24 weeks (6 months) prior to screening
- Active infection or current treatment with antibiotics within 2 weeks prior to screening
- History of HIV (ELISA and Western blot) test results
- Known active liver disease with aspartate aminotransferase or alanine aminotransferase levels greater than x3 the upper limit of normal
- Hepatitis B and/or hepatitis C treated with antiviral treatment within 4 weeks prior to screening
- History of allergy of VS-505 and its related components
- Receipt of any investigational drug within 4 weeks prior to screening
- Pregnant and breast-feeding women
- Other patients who in the opinion of the investigators are ineligible for the study
Sites / Locations
- LCR Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VS-505
Arm Description
750 mg capsule
Outcomes
Primary Outcome Measures
Inorganic phosphorus (Pi) change from baseline to end of treatment
Secondary Outcome Measures
Calcium (Ca) change from baseline to end of treatment
Ca x Pi change from baseline to end of treatment
intact parathyroid hormone change from baseline to end of treatment
Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL)
Rate of patients whose Pi reaches the goal between 1.13 mmol/L (3.5 mg/dL) and 1.94 mmol/L (6.0 mg/dL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02469467
Brief Title
A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
Official Title
A Dose Escalation Study of VS-505 to Evaluate the Tolerability, Safety and Efficacy in End Stage Renal Disease Patients Undergoing Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KDL Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose is to evaluate the tolerability, safety and efficacy of VS-505 when given with meal for 8 weeks to hemodialysis patients with hyperphosphatemia
Detailed Description
This study consists of 4 period; 1) screening period: up to 30 days, 2) first washout period: 2 weeks (remove existing phosphate binder effect), 3) treatment period: 8 weeks, and 4) second washout period: 2 weeks (remove VS-505 effect). VS-505 is orally administered with meal for 8 weeks. The starting dose of VS-505 is 1.50 g/day and the dose will be elevated step wise from 1.50 g to 2.25 g, 4.50 g and 6.75 g per day based on the safety assessment and plasma Pi level every 2 weeks during the treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hyperphosphatemia
Keywords
phosphate binder, dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VS-505
Arm Type
Experimental
Arm Description
750 mg capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
VS-505
Intervention Description
VS-505 is orally administered with meal for 8 weeks
Primary Outcome Measure Information:
Title
Inorganic phosphorus (Pi) change from baseline to end of treatment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Calcium (Ca) change from baseline to end of treatment
Time Frame
8 weeks
Title
Ca x Pi change from baseline to end of treatment
Time Frame
8 weeks
Title
intact parathyroid hormone change from baseline to end of treatment
Time Frame
8 weeks
Title
Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL)
Time Frame
8 weeks
Title
Rate of patients whose Pi reaches the goal between 1.13 mmol/L (3.5 mg/dL) and 1.94 mmol/L (6.0 mg/dL)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent given
Able to comply with the study procedures and medications
On a stable hemodialysis (HD) regimen (3 times per week) including hemodialysis and hemodiafiltration for ≥12 weeks at screening and during the study period
No change in prescribed dose or frequency of any of the following medications within 4 weeks prior to screening
Injectable iron agents
Oral or injectable active vitamin D3
Oral nutritional vitamin D
Calcimimetics
Calcium supplements
Anti-osteoporotic medication including bisphosphonates
Calcitonins
Must be willing to avoid intentional changes in diet throughout the study
Women of child-bearing potential or non-sterile male subjects and those who are sexually active with a non-sterile female partner must agree to use highly effective contraception
Plasma Pi level >1.94 mmol/L (6.0 mg/dL) to <3.23 mmol/L (10.0 mg/dL) after 2 weeks washout will qualify patients to enter the treatment period
Exclusion Criteria:
Blood purification therapy other than HD (hemodialysis and hemodiafiltration)
The plasma Pi level is >2.26 mmol/L (7.0 mg/dL) within the latest three tests prior to screening.
Variation of the plasma Pi is over 0.65 mmol/L (2.0 mg/dL) within the latest three tests prior to screening.
Pre-emptive or scheduled renal transplant
History of hemochromatosis or ferritin ≥1000 mcg/L
Oral iron agents including prescribed and over-the-counter drugs at screening.
Current clinically significant gastrointestinal (GI) disorder, including GI bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, chronic constipation, new diagnosis of peptic or duodenal ulcer disease, within 4 weeks prior to screening
History of gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening
Hypertension: Defined using pre-dialysis vital of diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg
Possible parathyroid intervention including surgical parathyroidectomy and percutaneous ethanol injection therapy during the study period
Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin
Severe cardiovascular disorders such as recent myocardial infarction; unstable angina; congested heart failure (NYHA class II or above) hospitalized within 24 weeks (6 months), valve stenosis, atrial fibrillation and arrhythmia
History of event by cerebrovascular disease or cardiovascular disease within 24 weeks (6 months) prior to screening
Active infection or current treatment with antibiotics within 2 weeks prior to screening
History of HIV (ELISA and Western blot) test results
Known active liver disease with aspartate aminotransferase or alanine aminotransferase levels greater than x3 the upper limit of normal
Hepatitis B and/or hepatitis C treated with antiviral treatment within 4 weeks prior to screening
History of allergy of VS-505 and its related components
Receipt of any investigational drug within 4 weeks prior to screening
Pregnant and breast-feeding women
Other patients who in the opinion of the investigators are ineligible for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
KDL inc
Phone
+81-3-3234-3400
Email
asao@kdl-japan.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Rosman, MD, Ph.D
Organizational Affiliation
LCR Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
LCR Clinical Research
City
Perth
State/Province
Western Australia
Country
Australia
Individual Site Status
Recruiting
12. IPD Sharing Statement
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A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
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