Chronic Kidney Disease Stages 3-5EASYNCT01263028
Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
A study testing Ergocalciferol supplementation in people with Chronic Kidney Disease Stages 3-5, run by Kaiser Permanente at 1 site in United States.
Trial summary
Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stages 3-5
- What is being tested?
- Ergocalciferol supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2011
- Phase
- Interventional
- 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
- Chronic kidney disease
- Age: >18yo
- Stable Hemoglobin (Hgb) for 1 month on stable dose of erythropoietin for 1 month (defined as erythropoietin dose within 15% of previous months erythropoietin dose)
- Unchanged maintenance oral or intravenous (IV) iron therapy for 1 month
- Serum 25-hydroxy Vitamin D levels < 30 ng/mL
- History of 25-hydroxy Vitamin D levels < 30 ng/mL currently on ergocalciferol replacement
Who cannot join
- On hemodialysis
- Chronic kidney disease 5
- Hypercalcemic (Calcium level > 11mg/dL)
- Pregnant female
- Iron deficient (iron saturation < 20%, Ferritin < 100ng/mL)
- Presence of active malignancy
Show all 14Show fewer
- Presence of active infections
- Presence of active inflammatory properties
- Presence of blood dyscrasias
- Active bleeding or bleeding within the past 3 months (other than menses)
- B12 deficiency
- Folate deficiency
- Blood transfusion during participation
- Parathyroid levels exceeding the expected levels allowed for the stage of a subjects Chronic kidney disease (Target Parathyroid in: Chronic kidney disease 3 35-70 pg/mL, Chronic kidney disease 4 70-110 pg/mL)
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
About this study
Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.
- Conditions
- Chronic Kidney Disease Stages 3-5
- Being tested
- Ergocalciferol supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol supplementationDrug
Vitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D.
| Study group | Role | What they receive |
|---|---|---|
| Ergocalciferol supplementation | Experimental | Not described Receives: Drug: Ergocalciferol supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
Measured: 24 Weeks
Secondary outcomes (4)
Change in Inflammatory Markers
Measured: 24 Weeks
Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels
Measured: 24 Weeks
Change in Iron Supplementation
Measured: 24 Weeks
Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Strong enrollment efforts resulted in few eligible subjects and high screen failures due to CKD patients with higher vitamin D levels than anticipated.
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 Chronic Kidney Disease Stages 3-5Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John J Sim, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263028
- Sponsor's protocol ID
- SIM2010001
- Acronym
- EASY
- Status last verified
- Mar 2015
- First submitted
- 16 Dec 2010
- Last updated
- 30 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
- ClinicalTrials.gov ID
- NCT01263028
- Acronym / sponsor ID
- EASY / SIM2010001
- Conditions
- Chronic Kidney Disease Stages 3-5
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strong enrollment efforts resulted in few eligible subjects and high screen failures due to CKD patients with higher vitamin D levels than anticipated.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Posted 20 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ergocalciferol supplementation | Experimental | Drug: Ergocalciferol supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic kidney disease
- Age: >18yo
- Stable Hemoglobin (Hgb) for 1 month on stable dose of erythropoietin for 1 month (defined as erythropoietin dose within 15% of previous months erythropoietin dose)
- Unchanged maintenance oral or intravenous (IV) iron therapy for 1 month
- Serum 25-hydroxy Vitamin D levels < 30 ng/mL
Key exclusion criteria (14 listed)
- On hemodialysis
- Chronic kidney disease 5
- Hypercalcemic (Calcium level > 11mg/dL)
- Pregnant female
- Iron deficient (iron saturation < 20%, Ferritin < 100ng/mL)
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 supplementationVitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D. | Drug | Ergocalciferol supplementation |
Primary outcome
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
Time frame: 24 Weeks
4 secondary outcomes
Change in Inflammatory Markers
Time frame: 24 Weeks
Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels
Time frame: 24 Weeks
Change in Iron Supplementation
Time frame: 24 Weeks
Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John J Sim, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergocalciferol supplementation in people with Chronic Kidney Disease Stages 3-5, run by Kaiser Permanente at 1 site 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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 Mar 2015. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2012). 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?
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements (time frame: 24 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 30 Mar 2015.