End Stage Renal DiseasePhase 4NCT01395823
Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
A Phase 4 study testing ergocalciferol supplementation in people with End Stage Renal Disease, run by Dialysis Clinic, Inc. at 12 sites in United States.
Trial summary
A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D supplementation, but only one of these is a prospective clinical trial, and it is a small, single center study lacking a control arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- ergocalciferol supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 470 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2011to Jun 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients treated with thrice weekly in-center hemodialysis (HD) for more than 90 days.
- Treated with EPO for at least 90 days. The mode of administration, intravenous (IV) or subcutaneous (SC), must remain the same for 90 days prior to enrollment.
- The method by which EPO is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the ceiling for the total EPO dose administered per week, if a ceiling is used, and the level of hemoglobin (Hgb) at which EPO is discontinued (Hgb cutoff), if a Hgb cutoff is used.
- The method by which IV Iron is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the serum ferritin and transferrin saturation (TSAT) targeted, if specific ferritin and TSAT targets are used
Who cannot join
- Patients with a serum calcium ≥10.5 mg/dL on at least one occasion in the past 30 days.
- Patients with a serum phosphorus >8.0 mg/dL on at least one occasion in the past 30 days.
- Active infection defined by the use of IV antibiotic use within the past 30 days.
- Current use of immunosuppressant medications other than low dose corticosteroids (prednisone <10 mg per day or equivalent)
- History of a hematological malignancy (e.g. multiple myeloma, leukemia).
- Sickle cell disease (sickle cell trait is not an exclusion).
Show all 19Show fewer
- Myelodysplasia requiring 1 or more blood transfusions in the past 3 months.
- Transfusion for any reason within the past 30 days.
- Medical conditions that cause a reduction in the absorption of oral vitamin D including Crohn's disease, celiac sprue, cystic fibrosis and surgical removal of part or all of the stomach or intestine.
- Medications that cause a reduction in the absorption of oral vitamin D including cholestyramine (Questran, others), colestipol (Colestid, others) and orlistat (Xenical, Alli).
- Known allergy/adverse reaction to ergocalciferol.
- Treated with ergocalciferol and/or cholecalciferol (except if part of a multi-vitamin) within the last 3 months.
- Average Kt/V < 1.3 on past three monthly labs. There must be at least 2 monthly Kt/V values in the past three months.
- Skipped more than 3 dialysis treatments (excluding planned missed treatments) within the past 3 months for reasons other than hospitalization.
- Life expectancy less than 6 months.
- Kidney transplantation planned in the next 6 months.
- Switch to peritoneal dialysis planned in the next 6 months.
- Pregnant or planning to become pregnant within the next 6 months. A pre-menopausal woman must agree to use contraception for the duration of the study. If a woman has not had menses in over 12 months, consider this patient to be menopausal.
- Unable or unwilling to give informed consent.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
DCI - Albany
Albany, Georgia, 31701
DCI - Boston
Boston, Massachusetts, 02111
DCI- Columbia
Columbia, Missouri, 65201
DCI - Kansas City
Kansas City, Missouri, 64131
DCI - Knoxville
Knoxville, Tennessee, 37924
DCI - Maryville
Maryville, Tennessee, 37804
DCI - New Brunswick
New Brunswick, New Jersey, 08903
DCI - North Brunswick
North Brunswick, New Jersey, 08902
DCI- Omaha
Omaha, Nebraska, 68131
DCI - Philadelphia
Philadelphia, Pennsylvania, 19129
DCI - Redding
Redding, California, 96003
DCI - Shreveport
Shreveport, Louisiana, 71103
About this study
Official title: Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients: A Randomized Clinical Trial
A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D supplementation, but only one of these is a prospective clinical trial, and it is a small, single center study lacking a control arm. The investigators propose to conduct a double blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to confirm safety and determine effects on Erythropoietin (EPO) dosing, active D dosing, and mineral metabolic parameters in hemodialysis patients.
- Conditions
- End Stage Renal Disease
- Being tested
- ergocalciferol supplementation, placebo
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergocalciferol supplementationDietary supplement
Also called vitamin D, D2
50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
placeboOther
Also called sugar pill
placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
| Study group | Role | What they receive |
|---|---|---|
| ergocalciferol supplementation | Other | Not described Receives: Dietary Supplement: ergocalciferol supplementation |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EPO Dose
The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dialysis Clinic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dana Miskulin, MD, Principal investigator, DCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395823
- Sponsor's protocol ID
- DCI-0002
- Status last verified
- Feb 2016
- First submitted
- 14 Jul 2011
- Last updated
- 14 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01395823
- Acronym / sponsor ID
- DCI-0002
- Conditions
- End Stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Dialysis Clinic, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Posted 14 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D supplementation, but only one of these is a prospective clinical trial, and it is a small, single center study lacking a control arm. The investigators propose to conduct a double blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to confirm safety and determine effects on Erythropoietin (EPO) dosing, active D dosing, and mineral metabolic parameters in hemodialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ergocalciferol supplementation | Other | Dietary Supplement: ergocalciferol supplementation |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients treated with thrice weekly in-center hemodialysis (HD) for more than 90 days.
- Treated with EPO for at least 90 days. The mode of administration, intravenous (IV) or subcutaneous (SC), must remain the same for 90 days prior to enrollment.
- The method by which EPO is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the ceiling for the total EPO dose administered per week, if a ceiling is used, and the level of hemoglobin (Hgb) at which EPO is discontinued (Hgb cutoff), if a Hgb cutoff is used.
- The method by which IV Iron is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the serum ferritin and transferrin saturation (TSAT) targeted, if specific ferritin and TSAT targets are used
Key exclusion criteria (19 listed)
- Patients with a serum calcium ≥10.5 mg/dL on at least one occasion in the past 30 days.
- Patients with a serum phosphorus >8.0 mg/dL on at least one occasion in the past 30 days.
- Active infection defined by the use of IV antibiotic use within the past 30 days.
- Current use of immunosuppressant medications other than low dose corticosteroids (prednisone <10 mg per day or equivalent)
- History of a hematological malignancy (e.g. multiple myeloma, leukemia).
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 |
|---|---|---|
| ergocalciferol supplementationAlso: vitamin D, D250,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly | Dietary supplement | ergocalciferol supplementation |
| placeboAlso: sugar pillplacebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly | Other | placebo |
Primary outcome
EPO Dose
Time frame: Baseline, 6 months
The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Dana Miskulin, MD principal investigator
DCI
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ergocalciferol supplementation in people with End Stage Renal Disease, run by Dialysis Clinic, Inc. at 12 sites in United States.
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 4 inclusion and 19 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: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EPO Dose (time frame: Baseline, 6 months). 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 14 Mar 2016.