Chronic Kidney DiseasePhase 4NCT00175149
Active Vitamin D Effect on Left Ventricular Hypertrophy
A Phase 4 study testing Alfacalcidiol in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by Per Ivarsen at 1 site in Denmark.
Trial summary
Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, Secondary Hyperparathyroidism, Left Ventricular Hypertrophy
- What is being tested?
- Alfacalcidiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2002to Dec 2008
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease (S-creatinin > 150 and < 600 mikroM)
- Secondary hyperparathyroidism (Between 3-8 times the upper limit of our PTH assay)
- Stable blood pressure during the last 6 months (less than (160/95)
- B-hemoglobin > 6 mmol/l
- EKG with sinus rhythm and no sign of Q-wave infarction
- Expected follow up 6 month
Who cannot join
- Pregnancy
- Kidney transplantation
- Malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction
Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH.
- Being tested
- Alfacalcidiol
- Keywords
- CKD 3-4
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfacalcidiolDrug
Alfacalcidiol are given to patientwith CKD 3-4 and secondary hyperparathyrodism. The PTH level is lowered to normal range. with increasing dose of alfacalcidiol and are followed for 6 month.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Given alfacalcidiol. Dose adjusted after PTH level Receives: Drug: Alfacalcidiol |
| 2 | No intervention | The untreated arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of dihydroxycholecalciferol on left ventricular hypertrophy
Measured: 6 month
Secondary outcomes (2)
Changes in the activity of the renin-angiotensin system
Measured: 6 month
Changes in left ventricular function
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Ivarsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Ivarsen, Aarhus University Hospital
- Investigators
- Per Ivarsen, MD, PhD, Principal investigator, Deparment of Renam Medicine C, Skejby HospitalPer Ivarsen, MD, PhD, Principal investigator, Deparment of Renal Medicine C, Skejby Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175149
- Sponsor's protocol ID
- EX 0203 DK
- Status last verified
- Dec 2015
- First submitted
- 11 Sep 2005
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction
- ClinicalTrials.gov ID
- NCT00175149
- Acronym / sponsor ID
- EX 0203 DK
- Keywords
- CKD 3-4
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Per IvarsenUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 15 Sep 2005 (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.
Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH.
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 | Drug: AlfacalcidiolGiven alfacalcidiol. Dose adjusted after PTH level |
| 2 | No intervention | –The untreated arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic kidney disease (S-creatinin > 150 and < 600 mikroM)
- Secondary hyperparathyroidism (Between 3-8 times the upper limit of our PTH assay)
- Stable blood pressure during the last 6 months (less than (160/95)
- B-hemoglobin > 6 mmol/l
- EKG with sinus rhythm and no sign of Q-wave infarction
Key exclusion criteria (3 listed)
- Pregnancy
- Kidney transplantation
- Malignant disease
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 |
|---|---|---|
| AlfacalcidiolAlfacalcidiol are given to patientwith CKD 3-4 and secondary hyperparathyrodism. The PTH level is lowered to normal range. with increasing dose of alfacalcidiol and are followed for 6 month. | Drug | 1 |
Primary outcome
The effect of dihydroxycholecalciferol on left ventricular hypertrophy
Time frame: 6 month
2 secondary outcomes
Changes in the activity of the renin-angiotensin system
Time frame: 6 month
Changes in left ventricular function
Time frame: 6 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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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.
Per Ivarsen, MD, PhD principal investigator
Deparment of Renam Medicine C, Skejby Hospital
Per Ivarsen, MD, PhD principal investigator
Deparment of Renal Medicine C, Skejby Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfacalcidiol in people with Chronic Kidney Disease and Secondary Hyperparathyroidism, run by Per Ivarsen at 1 site in Denmark.
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 3 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 8 Dec 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
The effect of dihydroxycholecalciferol on left ventricular hypertrophy (time frame: 6 month). 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 8 Dec 2015.