Chronic Kidney Disease Stage 3 and 4Phase 3UPGRADENCT01173848
Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients
A Phase 3 study testing Ergocalciferol and Cholecalciferol in people with Chronic Kidney Disease Stage 3 and 4, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Kidney Disease Stage 3 and 4
- What is being tested?
- Ergocalciferol and Cholecalciferol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 18 Oct 2011
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Chronic kidney disease stage 3-4 (eGFR 15-59 mL/min/1.73m2 body surface area, calculated using the MDRD Study equation GFR calculator)
- Hypovitaminosis D (serum 25OHD < 31 ng/mL)
- Secondary hyperparathyroidism (Intact PTH > 70 pg/mL for stage 3, and iPTH > 110 pg/mL for stage 4)
Who cannot join
- Initiation of vitamin D therapy between the time of the lab draw used for screening and the screening process
- History of liver failure
- History of intestinal malabsorption or chronic diarrhea
- Serum calcium level greater than 10.2 mg/dL
- Treatment with an activated vitamin D formulation (calcitriol, doxercalciferol or paricalcitol) within the past 6 months
- Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
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- Primary hyperparathyroidism, active of a prior history of such
- Active malignancy excluding basal cell or localized squamous cell skin cancer
- Subject is pregnant (e.g. positive HCG test) or breast-feeding
- Refusal to use highly effective contraceptive measures (as determined by the investigator) throughout the treatment phase of the study
- Serum phosphorus level greater than 4.5 or treatment with an oral phosphate binder within the past 6 months
- Treatment with cinacalcet or other calcimimetic within the past 6 months
- Anticipated dialysis within 6 months after randomization
- Inability to swallow tablets
- Known sensitivity, intolerance, or other adverse response to the study drugs which would prevent compliance with study medication
- Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
- Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
- Current treatment with vitamin D 50,000 IU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study to Evaluate the Effectiveness of Cholecalciferol Versus Ergocalciferol Following Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines for Vitamin D Therapy in Stages 3 & 4 Chronic Kidney Disease (CKD) Patients
The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis.
Read the detailed description
Subjects will be randomized and assigned to one of the treatment groups (D2 or D3). Subjects will be dispensed a supply of 1.25 mg cholecalciferol/ergocalciferol tablets, depending on their randomization outcome. The number of pills dispensed and medication instructions will be determined by their 25OHD level and K/DOQI guidelines. Both Study personnel and subject will be blinded to randomization group.
The treatment phase will be 24 weeks in duration with lab visits every 6 weeks. All laboratory specimens will be drawn either at CCF Main hospital labs or at a CCF family Health center lab. Subjects will be have telephone interviews at week 4, 10, 16, 22 and possibly at weeks 28 and 34.
- Conditions
- Chronic Kidney Disease Stage 3 and 4
- Being tested
- Ergocalciferol, Cholecalciferol
- Keywords
- CKD, Vitamin D
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months
CholecalciferolDrug
1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D2 | Active comparator | Patients randomized to take vitamin D2 Receives: Drug: Ergocalciferol |
| Vitamin D3 | Active comparator | Patient's randomized to take Vitamin D3 Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects Achieving Normal Vitamin D Levels
Measured: within 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completion18 Oct 2011
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 Stage 3 and 4Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James F Simon, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173848
- Sponsor's protocol ID
- Cleveland Clinic
- Acronym
- UPGRADE
- Status last verified
- Jul 2013
- First submitted
- 30 Jul 2010
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Effectiveness of Cholecalciferol Versus Ergocalciferol Following Kidney Disease Outcomes Quality Initiative (K/DOQI) Guidelines for Vitamin D Therapy in Stages 3 & 4 Chronic Kidney Disease (CKD) Patients
- ClinicalTrials.gov ID
- NCT01173848
- Acronym / sponsor ID
- UPGRADE / Cleveland Clinic
- Conditions
- Chronic Kidney Disease Stage 3 and 4
- Keywords
- CKD, Vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- 18 Oct 2011 (actual)
- First posted
- 2 Aug 2010 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effectiveness of vitamin D3 versus vitamin D2 in raising vitamin D levels and suppressing parathyroid hormone levels in patients with kidney disease who are not on dialysis.
Detailed description
Subjects will be randomized and assigned to one of the treatment groups (D2 or D3). Subjects will be dispensed a supply of 1.25 mg cholecalciferol/ergocalciferol tablets, depending on their randomization outcome. The number of pills dispensed and medication instructions will be determined by their 25OHD level and K/DOQI guidelines. Both Study personnel and subject will be blinded to randomization group.
The treatment phase will be 24 weeks in duration with lab visits every 6 weeks. All laboratory specimens will be drawn either at CCF Main hospital labs or at a CCF family Health center lab. Subjects will be have telephone interviews at week 4, 10, 16, 22 and possibly at weeks 28 and 34.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D2 | Active comparator | Drug: ErgocalciferolPatients randomized to take vitamin D2 |
| Vitamin D3 | Active comparator | Drug: CholecalciferolPatient's randomized to take Vitamin D3 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years
- Chronic kidney disease stage 3-4 (eGFR 15-59 mL/min/1.73m2 body surface area, calculated using the MDRD Study equation GFR calculator)
- Hypovitaminosis D (serum 25OHD < 31 ng/mL)
- Secondary hyperparathyroidism (Intact PTH > 70 pg/mL for stage 3, and iPTH > 110 pg/mL for stage 4)
Key exclusion criteria (18 listed)
- Initiation of vitamin D therapy between the time of the lab draw used for screening and the screening process
- History of liver failure
- History of intestinal malabsorption or chronic diarrhea
- Serum calcium level greater than 10.2 mg/dL
- Treatment with an activated vitamin D formulation (calcitriol, doxercalciferol or paricalcitol) within the past 6 months
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 |
|---|---|---|
| Ergocalciferol1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months | Drug | Vitamin D2 |
| Cholecalciferol1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months | Drug | Vitamin D3 |
Primary outcome
Subjects Achieving Normal Vitamin D Levels
Time frame: within 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- 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.
James F Simon, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ergocalciferol and Cholecalciferol in people with Chronic Kidney Disease Stage 3 and 4, run by The Cleveland Clinic 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 4 inclusion and 18 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 4 Apr 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Apr 2017). 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?
Subjects Achieving Normal Vitamin D Levels (time frame: within 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 4 Apr 2017.