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

NCT02469467 | Unknown Phase 1

• 1 other identifier: VDKDL001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Renal Disease; Hyperphosphatemia

Keywords

phosphate binder; dialysis

Outcome Measures

Primary Outcomes (1)

• Inorganic phosphorus (Pi) change from baseline to end of treatment

  8 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

VS-505

EXPERIMENTAL

750 mg capsule

Dietary Supplement: VS-505

Interventions

VS-505 DIETARY_SUPPLEMENT

VS-505 is orally administered with meal for 8 weeks

VS-505

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KDL Inc.: lead

Study Sites (1)

LCR Clinical Research

Perth, Western Australia, Australia

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperphosphatemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Johan Rosman, MD, Ph.D

  LCR Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KDL inc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 11, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

AU (1)