CKD Stage 3/4NCT02018133
Identification of Markers for Determining the Efficacy of Vitamin D Receptor Activator Therapy in Stage 3/4 CKD Patients
An observational study of CKD Stage 3/4, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this study is to identify genes that are responsive to paricalcitol (active vitamin D) therapy. Scientists have found that over 30 different types of cells in the body respond to vitamin D therapy, including blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD Stage 3/4
- What is being tested?
- Vitamin D 2mg daily for 2 weeks oral paricalcitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2012
- Phase
- Observational
- 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
Study population: Chronic kidney disease stage 3/4, with PTH >70 pg/ml and if on ACEI/ARB, the dose is optimized or stable
Who may be able to join
- Chronic kidney disease stage 3/4
- PTH: >70 pg/ml
- If on ACEI/ARB, optimized and stable dose
Who cannot join
- Failure to provide informed consent
- Prior active vitamin D oral or parenteral treatment, including calcitriol, paricalcitol and doxercalciferol
- Glomerulonephritis requiring active treatment with immunosuppressive therapy
- Serum phosphorus: > 5.2 mg/dL
- Serum calcium (corrected for albumin): > 10.0 mg/dL
- Clinical unstable medical conditions (other than CKD)
Show all 11Show fewer
- Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
- History of malignancy, other than basal cell carcinoma of the skin
- History of hypersensitivity to vitamin D or its analogs
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
The purpose of this study is to identify genes that are responsive to paricalcitol (active vitamin D) therapy. Scientists have found that over 30 different types of cells in the body respond to vitamin D therapy, including blood vessels. Low levels of vitamin D may reduce the amount of calcium in the blood, increase the amount of parathyroid hormone (PTH) and cause the parathyroid gland (small gland located in the neck) to get bigger which is called secondary hyperparathyroidism (SHPT). Also, low levels of vitamin D may worsen the heart disease seen in dialysis patients. Paricalcitol, a man-made active vitamin D, is a replacement for vitamin D for preventing and treating SHPT. Studies that followed patients on dialysis have found: (1) differences in death rates between those who received active vitamin D compared with no activated vitamin D, and (2) a survival benefit in chronic kidney disease (CKD) patients receiving paricalcitol, over calcitriol (natural active vitamin D). Researchers have considered that giving paricalcitol to people with (CKD) may also prevent or slow the progression of heart disease.
Currently, physicians can only tell how well the vitamin D is working by measuring PTH concentrations. This study aims to identify markers in the blood that can be used to determine the efficacy of Vitamin D therapy.
Read the detailed description
After baseline information and laboratory tests are obtained, subjects will be randomized to receive either oral paricalcitol at 2 mcg daily for 2 weeks or placebo. After a washout period of 4 weeks, those subjects who received paricalcitol will receive placebo for 2 weeks and those who received placebo will receive paricalcitol for 2 weeks. A simple blood draw will be obtained from the patient on days 0, 1, and 14 of each treatment arm, and they will also be assessed for side effects at the end of each treatment.
The blood obtained during these visits will be analyzed for any changes that may have occurred in the white blood cells (WBC) and/or plasma. These samples will be tested to see if there are any markers in the blood that changed after treatment with vitamin D. The samples collected will be temporarily stored in the research laboratory and subsequently sent to a separate laboratory (Genus Systems Company) in batches for analysis.
- Conditions
- CKD Stage 3/4
- Being tested
- Vitamin D 2mg daily for 2 weeks oral paricalcitol, Placebo
- Keywords
- CKD, chronic, kidney, vitamin D
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 2mg daily for 2 weeks oral paricalcitolDrug
Also called Zemplar
vitamin D 2 capsules daily
PlaceboDrug
placebo 2 capsule daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D or Placebo | Take vitamin D for 2 weeks. 2mg daily before meal Receives: Drug: Vitamin D 2mg daily for 2 weeks oral paricalcitol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
examine the gene expression pattern in white blood cells obtained from Stage 3/4 CKD patients before and after paricalcitol treatment
determine gene expression
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startDec 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD Stage 3/4Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Alan Lau, University of Illinois Chicago
- Investigators
- Alan Lau, PharmD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018133
- Sponsor's protocol ID
- 2008-0929
- Other IDs
- BMK-001
- Status last verified
- Aug 2020
- First submitted
- 20 Jun 2012
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Markers for Determining the Efficacy of Vitamin D Receptor Activator Therapy in Stage 3/4 CKD Patients
- ClinicalTrials.gov ID
- NCT02018133
- Acronym / sponsor ID
- 2008-0929
- Conditions
- CKD Stage 3/4
- Keywords
- CKD, chronic, kidney, vitamin D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Dec 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Dec 2013 (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 of this study is to identify genes that are responsive to paricalcitol (active vitamin D) therapy. Scientists have found that over 30 different types of cells in the body respond to vitamin D therapy, including blood vessels. Low levels of vitamin D may reduce the amount of calcium in the blood, increase the amount of parathyroid hormone (PTH) and cause the parathyroid gland (small gland located in the neck) to get bigger which is called secondary hyperparathyroidism (SHPT). Also, low levels of vitamin D may worsen the heart disease seen in dialysis patients. Paricalcitol, a man-made active vitamin D, is a replacement for vitamin D for preventing and treating SHPT. Studies that followed patients on dialysis have found: (1) differences in death rates between those who received active vitamin D compared with no activated vitamin D, and (2) a survival benefit in chronic kidney disease (CKD) patients receiving paricalcitol, over calcitriol (natural active vitamin D). Researchers have considered that giving paricalcitol to people with (CKD) may also prevent or slow the progression of heart disease.
Currently, physicians can only tell how well the vitamin D is working by measuring PTH concentrations. This study aims to identify markers in the blood that can be used to determine the efficacy of Vitamin D therapy.
Detailed description
After baseline information and laboratory tests are obtained, subjects will be randomized to receive either oral paricalcitol at 2 mcg daily for 2 weeks or placebo. After a washout period of 4 weeks, those subjects who received paricalcitol will receive placebo for 2 weeks and those who received placebo will receive paricalcitol for 2 weeks. A simple blood draw will be obtained from the patient on days 0, 1, and 14 of each treatment arm, and they will also be assessed for side effects at the end of each treatment.
The blood obtained during these visits will be analyzed for any changes that may have occurred in the white blood cells (WBC) and/or plasma. These samples will be tested to see if there are any markers in the blood that changed after treatment with vitamin D. The samples collected will be temporarily stored in the research laboratory and subsequently sent to a separate laboratory (Genus Systems Company) in batches for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D or Placebo | – | Drug: Vitamin D 2mg daily for 2 weeks oral paricalcitol, Drug: PlaceboTake vitamin D for 2 weeks. 2mg daily before meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic kidney disease stage 3/4, with PTH >70 pg/ml and if on ACEI/ARB, the dose is optimized or stable
Key inclusion criteria (3 listed)
- Chronic kidney disease stage 3/4
- PTH: >70 pg/ml
- If on ACEI/ARB, optimized and stable dose
Key exclusion criteria (11 listed)
- Failure to provide informed consent
- Prior active vitamin D oral or parenteral treatment, including calcitriol, paricalcitol and doxercalciferol
- Glomerulonephritis requiring active treatment with immunosuppressive therapy
- Serum phosphorus: > 5.2 mg/dL
- Serum calcium (corrected for albumin): > 10.0 mg/dL
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 |
|---|---|---|
| Vitamin D 2mg daily for 2 weeks oral paricalcitolAlso: Zemplarvitamin D 2 capsules daily | Drug | Vitamin D or Placebo |
| Placeboplacebo 2 capsule daily | Drug | Vitamin D or Placebo |
Primary outcome
examine the gene expression pattern in white blood cells obtained from Stage 3/4 CKD patients before and after paricalcitol treatment
Time frame: 2 weeks
determine gene expression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
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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.
Alan Lau, PharmD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD Stage 3/4, run by University of Illinois Chicago 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 3 inclusion and 11 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 17 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
examine the gene expression pattern in white blood cells obtained from Stage 3/4 CKD patients before and after paricalcitol treatment (time frame: 2 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 17 Aug 2020.