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A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469467
Recruitment Status : Unknown
Verified February 2016 by KDL Inc..
Recruitment status was:  Recruiting
First Posted : June 11, 2015
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
KDL Inc.

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

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Hyperphosphatemia Dietary Supplement: VS-505 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VS-505
750 mg capsule
Dietary Supplement: VS-505
VS-505 is orally administered with meal for 8 weeks




Primary Outcome Measures :
  1. Inorganic phosphorus (Pi) change from baseline to end of treatment [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Calcium (Ca) change from baseline to end of treatment [ Time Frame: 8 weeks ]
  2. Ca x Pi change from baseline to end of treatment [ Time Frame: 8 weeks ]
  3. intact parathyroid hormone change from baseline to end of treatment [ Time Frame: 8 weeks ]
  4. Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL) [ Time Frame: 8 weeks ]
  5. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    1. Injectable iron agents
    2. Oral or injectable active vitamin D3
    3. Oral nutritional vitamin D
    4. Calcimimetics
    5. Calcium supplements
    6. Anti-osteoporotic medication including bisphosphonates
    7. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469467


Contacts
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Contact: KDL inc +81-3-3234-3400 asao@kdl-japan.com

Locations
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Australia, Western Australia
LCR Clinical Research Recruiting
Perth, Western Australia, Australia
Sponsors and Collaborators
KDL Inc.
Investigators
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Principal Investigator: Johan Rosman, MD, Ph.D LCR Clinical Research
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Responsible Party: KDL Inc.
ClinicalTrials.gov Identifier: NCT02469467    
Other Study ID Numbers: VDKDL001
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Keywords provided by KDL Inc.:
phosphate binder
dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases