End Stage Renal DiseasePhase 1/2NCT02469467
A Dose Escalation Study of VS-505 in End Stage Renal Disease Patients Undergoing Hemodialysis
A Phase 1/2 study testing VS-505 in people with End Stage Renal Disease and Hyperphosphatemia, run by KDL Inc. at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hyperphosphatemia
- What is being tested?
- VS-505
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
LCR Clinical Research
Perth, Western Australia
About this study
Official title: 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
Read the 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.
- Conditions
- End Stage Renal Disease, Hyperphosphatemia
- Being tested
- VS-505
- Keywords
- phosphate binder, dialysis
- Medical subject headings
- Kidney Failure, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS-505Dietary supplement
VS-505 is orally administered with meal for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| VS-505 | Experimental | 750 mg capsule Receives: Dietary Supplement: VS-505 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inorganic phosphorus (Pi) change from baseline to end of treatment
Measured: 8 weeks
Secondary outcomes (5)
Calcium (Ca) change from baseline to end of treatment
Measured: 8 weeks
Ca x Pi change from baseline to end of treatment
Measured: 8 weeks
intact parathyroid hormone change from baseline to end of treatment
Measured: 8 weeks
Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL)
Measured: 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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KDL Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johan Rosman, MD, Ph.D, Principal investigator, LCR Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469467
- Sponsor's protocol ID
- VDKDL001
- Status last verified
- Feb 2016
- First submitted
- 1 Jun 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study of VS-505 to Evaluate the Tolerability, Safety and Efficacy in End Stage Renal Disease Patients Undergoing Hemodialysis
- ClinicalTrials.gov ID
- NCT02469467
- Acronym / sponsor ID
- VDKDL001
- Conditions
- End Stage Renal Disease, Hyperphosphatemia
- Keywords
- phosphate binder, dialysis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- KDL Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VS-505 | Experimental | Dietary Supplement: VS-505750 mg capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Must be willing to avoid intentional changes in diet throughout the study
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VS-505VS-505 is orally administered with meal for 8 weeks | Dietary supplement | VS-505 |
Primary outcome
Inorganic phosphorus (Pi) change from baseline to end of treatment
Time frame: 8 weeks
5 secondary outcomes
Calcium (Ca) change from baseline to end of treatment
Time frame: 8 weeks
Ca x Pi change from baseline to end of treatment
Time frame: 8 weeks
intact parathyroid hormone change from baseline to end of treatment
Time frame: 8 weeks
Rate of patients whose Pi reduction is 0.65 mmol/L (2.0 mg/dL)
Time frame: 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)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Rosman, MD, Ph.D principal investigator
LCR Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VS-505 in people with End Stage Renal Disease and Hyperphosphatemia, run by KDL Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KDL inc (+81-3-3234-3400, asao@kdl-japan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inorganic phosphorus (Pi) change from baseline to end of treatment (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.