End Stage Renal DiseasePhase 2NCT00656032
Vitamin D, Insulin Resistance and Inflammation in ESRD
A Phase 2 study testing paricalcitol and cinacalcet in people with End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin… 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?
- paricalcitol and cinacalcet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2010
- Phase
- Phase 2
- 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
Who may be able to join
- CKD and receiving hemodialysis for ≥ 3months
- Kt/V ≥ 1.2
- ≥ 18 years of age
- Medically stable
- AVF or PTFE dialysis access
- No acute inflammatory disease within 4 weeks prior to the study
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- On stable dose of Paricalcitol for 4 weeks prior to the study
- iPTH value between 150 - 1500 within the past 3 months
- Ca < 10.5
- PO4 < 10
Who cannot join
- Pregnancy
- Intolerance to the study medication
- Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
- Type 1 Diabetes mellitus
- Uncontrolled Type 2 Diabetes mellitus (HbA1c > 10)
- Hospitalization within 1 month prior to the study
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- Malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 250 ml/min)
- Presence of hemodialysis catheter
- Patients receiving steroids and/or other immunosuppressive agents (> 10 mg prednisone qd)
- BMI < 25 and > 45
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.
- Conditions
- End Stage Renal Disease
- Being tested
- paricalcitol, cinacalcet
- Keywords
- insulin resistance, end stage renal disease
- Medical subject headings
- Kidney Failure, Chronic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paricalcitolOther
Also called zemplar
1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks
cinacalcetOther
Also called sensipar
0 to 180 mg administered orally every day for either 8 weeks or 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | SOC medication for treatment of renal osteodystrophy Receives: Other: paricalcitol |
| 2 | Active comparator | alternate SOC medication for treatment of renal osteodystrophy Receives: Other: cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
An improvement in insulin sensitivity
Measured: 8 weeks
Secondary outcomes (2)
A change in insulin signaling
Measured: 8 weeks
A decrease in concentration of plasma pro-inflammatory cytokines
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 posted10 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ikizler, Vanderbilt University
- Investigators
- Alp Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656032
- Sponsor's protocol ID
- 080074
- Status last verified
- Jan 2012
- First submitted
- 4 Apr 2008
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D, Insulin Resistance and Inflammation in ESRD
- ClinicalTrials.gov ID
- NCT00656032
- Acronym / sponsor ID
- 080074
- Conditions
- End Stage Renal Disease
- Keywords
- insulin resistance, end stage renal disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 10 Apr 2008 (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 broad goal of this study is to understand the mechanisms by which Vitamin D receptor activation leads to changes in insulin signaling in advanced uremia. We hypothesize that 1,25-Dihydroxyvitamin D3 deficiency due to advanced chronic kidney disease leads to insulin resistance and that administration of a vitamin D3 analog will restore insulin sensitivity in End Stage Renal Disease patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: paricalcitolSOC medication for treatment of renal osteodystrophy |
| 2 | Active comparator | Other: cinacalcetalternate SOC medication for treatment of renal osteodystrophy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- CKD and receiving hemodialysis for ≥ 3months
- Kt/V ≥ 1.2
- ≥ 18 years of age
- Medically stable
- AVF or PTFE dialysis access
Key exclusion criteria (10 listed)
- Pregnancy
- Intolerance to the study medication
- Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease)
- Type 1 Diabetes mellitus
- Uncontrolled Type 2 Diabetes mellitus (HbA1c > 10)
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: zemplar1 to 20 micrograms administered via IV; every other day, 3 days per week, for 8 weeks | Other | 1 |
| cinacalcetAlso: sensipar0 to 180 mg administered orally every day for either 8 weeks or 16 weeks | Other | 2 |
Primary outcome
An improvement in insulin sensitivity
Time frame: 8 weeks
2 secondary outcomes
A change in insulin signaling
Time frame: 8 weeks
A decrease in concentration of plasma pro-inflammatory cytokines
Time frame: 8 weeks
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 11 Jan 2012.
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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.
Alp Ikizler, MD principal investigator
Vanderbilt University Medical Center
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 and cinacalcet in people with End Stage Renal Disease, run by Vanderbilt University 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 10 inclusion and 10 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 11 Jan 2012. 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?
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?
An improvement in insulin sensitivity (time frame: 8 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 11 Jan 2012.