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A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

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

NCT02469467•KDL Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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
+11 more criteria

Locations (1)

LCR Clinical Research

Perth, Western Australia, Australia

Key Dates

Start Date

June 1, 2015

Primary Completion Date

October 1, 2016

Completion Date

December 1, 2016

Last Updated

February 8, 2016

Enrollment

ESTIMATED participants

Conditions

End Stage Renal DiseaseHyperphosphatemia

Interventions

VS-505

DIETARY_SUPPLEMENT

Contacts

KDL inc

CONTACT

+81-3-3234-3400 asao@kdl-japan.com

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

NCT06933472

HyperphosphatemiaChronic Kidney Disease, Receiving Dialysis+2 more

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RECRUITING

EndoForce Post Approval Study

NCT07146854

End Stage Renal Disease (ESRD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

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