Chronic Kidney DiseasePhase 2NCT01003275
Metabolic Effects of Paricalcitol
A Phase 2 study testing Paricalcitol in people with Chronic Kidney Disease, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Paricalcitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2011
- Phase
- Phase 2
- 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
- Estimated glomerular filtration rate of 15-59 mL/min/1.73m2
- Fasting glucose 100-125 mg/dL
- 18 years and older
Who cannot join
- Diagnosed with diabetes mellitus
- Use of diabetes medications (insulin or oral hypoglycemics)
- Prior dialysis or transplantation
- Planning to leave the area within 6 months
- Participation in another clinical trial within 30 days
- Treatment with paricalcitol, calcitriol, or corticosteroids in the preceding 8 weeks
Show all 13Show fewer
- Serum calcium more than 10.2 mg/dL
- Pregnancy or breast-feeding
- Change in dose (within 8 weeks) of Fibrates, Niacin, ACE inhibitors, Angiotensin receptor blockers, Thiazide diuretics, Beta-blockers, Cholecalciferol or Ergocalciferol
- Incontinent of urine
- Cancer (other than skin cancer) within 5 years
- Tuberculosis
- Sarcoidosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Paricalcitol on Glucose Tolerance, Immune Cell Function, and Oxidative Stress in Stage 3-4 Chronic Kidney Disease
The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).
Read the detailed description
Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD.
This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.
- Conditions
- Chronic Kidney Disease
- Being tested
- Paricalcitol, Placebo
- Keywords
- Chronic kidney disease, Vitamin D, Paricalcitol, Placebo, Kidney, Renal, Oxidative Stress, Immune cell function, Glucose, Glucose tolerance
- 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.
ParicalcitolDrug
Also called Zemplar
Two 1 mcg soft gels by mouth daily for 8 weeks
PlaceboDrug
Two soft gels by mouth daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol followed by placebo | Active comparator | Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. Receives: Drug: Paricalcitol; Drug: Placebo |
| Placebo followed by paricalcitol | Active comparator | Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks. Receives: Drug: Paricalcitol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Area Under the Curve (AUC)
Glucose AUC during a 2-hour oral glucose tolerance test
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 posted28 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2011
- Study completionNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Ian deBoer, University of Washington
- Investigators
- Ian H de Boer, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003275
- Sponsor's protocol ID
- 35501-D
- Status last verified
- Apr 2014
- First submitted
- 26 Oct 2009
- Last updated
- 28 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
de Boer IH, Sachs M, Hoofnagle AN, Utzschneider KM, Kahn SE, Kestenbaum B, Himmelfarb J. Paricalcitol does not improve glucose metabolism in patients with stage 3-4 chronic kidney disease. Kidney Int. 2013 Feb;83(2):323-30. doi: 10.1038/ki.2012.311. Epub 2012 Aug 22.
PubMed 22913981
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Paricalcitol on Glucose Tolerance, Immune Cell Function, and Oxidative Stress in Stage 3-4 Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01003275
- Acronym / sponsor ID
- 35501-D
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Vitamin D, Paricalcitol, Placebo, Kidney, Renal, Oxidative Stress, Immune cell function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Oct 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Posted 27 Sep 2013
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 determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).
Detailed description
Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD.
This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol followed by placebo | Active comparator | Drug: Paricalcitol, Drug: PlaceboParticipants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. |
| Placebo followed by paricalcitol | Active comparator | Drug: Paricalcitol, Drug: PlaceboParticipants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Estimated glomerular filtration rate of 15-59 mL/min/1.73m2
- Fasting glucose 100-125 mg/dL
- 18 years and older
Key exclusion criteria (13 listed)
- Diagnosed with diabetes mellitus
- Use of diabetes medications (insulin or oral hypoglycemics)
- Prior dialysis or transplantation
- Planning to leave the area within 6 months
- Participation in another clinical trial within 30 days
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 |
|---|---|---|
| ParicalcitolAlso: ZemplarTwo 1 mcg soft gels by mouth daily for 8 weeks | Drug | Paricalcitol followed by placebo, Placebo followed by paricalcitol |
| PlaceboTwo soft gels by mouth daily for 8 weeks | Drug | Paricalcitol followed by placebo, Placebo followed by paricalcitol |
Primary outcome
Glucose Area Under the Curve (AUC)
Time frame: 8 weeks
Glucose AUC during a 2-hour oral glucose tolerance test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22913981de Boer IH, Sachs M, Hoofnagle AN, Utzschneider KM, Kahn SE, Kestenbaum B, Himmelfarb J. Paricalcitol does not improve glucose metabolism in patients with stage 3-4 chronic kidney disease. Kidney Int. 2013 Feb;83(2):323-30. doi: 10.1038/ki.2012.311. Epub 2012 Aug 22.
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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.
Ian H de Boer, MD, MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paricalcitol in people with Chronic Kidney Disease, run by University of Washington 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 13 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 28 Apr 2014. 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 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?
Yes. Results are posted in the registry (first posted 27 Sep 2013). 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?
Glucose Area Under the Curve (AUC) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01003275, which also lists 1 linked publication.
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 28 Apr 2014.