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

A Dose Escalation Study of VS-505 to Evaluate the Tolerability, Safety and Efficacy in End Stage Renal Disease Patients Undergoing Hemodialysis

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

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Disease; Hyperphosphatemia
• Intervention / Treatment: Dietary supplement: VS-505

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia
      • Recruiting
      • LCR Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VS-505; 750 mg capsule	Dietary supplement: VS-505; VS-505 is orally administered with meal for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Inorganic phosphorus (Pi) change from baseline to end of treatment	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Calcium (Ca) change from baseline to end of treatment	8 weeks
Ca x Pi change from baseline to end of treatment	8 weeks
intact parathyroid hormone change from baseline to end of treatment	8 weeks
Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL)	8 weeks
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)	8 weeks

Collaborators and Investigators

• Sponsor: KDL Inc.
• Investigators: Principal Investigator: Johan Rosman, MD, Ph.D, LCR Clinical Research

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 1, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Estimate): February 8, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: dialysis; phosphate binder
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Phosphorus Metabolism Disorders; Kidney Diseases; Kidney Failure, Chronic; Hyperphosphatemia
• Other Study ID Numbers: VDKDL001