Chronic Kidney DiseasePhase 2NCT01136564
Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease
A Phase 2 study testing Zemplar in people with Chronic Kidney Disease, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial summary
Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. 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?
- Zemplar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2010to Dec 2011
- 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
- Kidney disease corresponding to eGFR: 15-59 ml/min
- Albuminuria > 30 mg/l
Who cannot join
- Total parathyroidectomy
- Diabetes Mellitus
- Cancer
- Illicit drug or alcohol abuse
- Pregnancy og nursing
- Ongoing NSAID or corticosteroid treatment
Show all 10Show fewer
- b-hemoglobin < 6 mmol/l
- p-albumin < 25 mmol/l
- Clinically significant hypercalcemia
- Office blood pressure > 170/105 mmHg that despite antihypertensive treatment still is > 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease
Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.
- Conditions
- Chronic Kidney Disease
- Being tested
- Zemplar, Placebo
- Keywords
- paricalcitol, vitamin d, kidney disease, renin, proteinuria
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZemplarDrug
2 capsules of 1 microgram daily
PlaceboDrug
2 capsules daily
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Active comparator | Not described Receives: Drug: Zemplar |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma renin concentration
Measured: 6 weeks
Secondary outcomes (26)
Urinary albumin excretion
Measured: 6 weeks
GFR
Measured: 6 weeks
Fractional excretion of sodium
Measured: 6 weeks
Urinary excretion of aquaporin-2
Measured: 6 weeks
Urinary excretion of ENaC-beta
Measured: 6 weeks
Urinary excretion of NCC
Measured: 6 weeks
Plasma concentration of aldosterone
Measured: 6 weeks
Plasma concentration of angiotensin-II
Measured: 6 weeks
Plasma concentration of ADH
Measured: 6 weeks
Plasma concentration of atrial natriuretic peptide
Measured: 6 weeks
Plasma concentration of brain natriuretic peptide
Measured: 6 weeks
Plasma concentration of endothelin
Measured: 6 weeks
24-hr ambulatory blood pressure
Measured: 6 weeks
Central blood pressure
Measured: 6 weeks
Pulse wave velocity
Measured: 6 weeks
augmentation index
Measured: 6 weeks
Plasma concentration of ionized calcium
Measured: 6 weeks
Plasma concentration of phosphate
Measured: 6 weeks
Plasma concentration of alkaline phosphatase
Measured: 6 weeks
Plasma concentration of Parathyroid hormon
Measured: 6 weeks
Plasma concentration of 25-hydroxy-vitamin D
Measured: 6 weeks
Plasma concentration of ultrasensitive CRP
Measured: 6 weeks
Plasma concentration of TNF-alpha
Measured: 6 weeks
Plasma concentration of TGF-beta
Measured: 6 weeks
Urinary excretion of calcium
Measured: 6 weeks
Plasma concentration of ADMA
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Erling B Pedersen, Prof, MSci, Principal investigator, Department of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136564
- Sponsor's protocol ID
- EBP-TL-2010
- Other IDs
- 2009-017619-14, 2009
- Status last verified
- Jan 2012
- First submitted
- 2 Jun 2010
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larsen T, Mose FH, Bech JN, Pedersen EB. Effect of paricalcitol on renin and albuminuria in non-diabetic stage III-IV chronic kidney disease: a randomized placebo-controlled trial. BMC Nephrol. 2013 Jul 26;14:163. doi: 10.1186/1471-2369-14-163.
PubMed 23889806
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01136564
- Acronym / sponsor ID
- EBP-TL-2010
- Conditions
- Chronic Kidney Disease
- Keywords
- paricalcitol, vitamin d, kidney disease, renin, proteinuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Jun 2010 (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.
Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.
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 | Active comparator | Drug: Zemplar |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Kidney disease corresponding to eGFR: 15-59 ml/min
- Albuminuria > 30 mg/l
Key exclusion criteria (10 listed)
- Total parathyroidectomy
- Diabetes Mellitus
- Cancer
- Illicit drug or alcohol abuse
- Pregnancy og nursing
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 |
|---|---|---|
| Zemplar2 capsules of 1 microgram daily | Drug | Paricalcitol |
| Placebo2 capsules daily | Drug | Placebo |
Primary outcome
plasma renin concentration
Time frame: 6 weeks
26 secondary outcomes
Urinary albumin excretion
Time frame: 6 weeks
GFR
Time frame: 6 weeks
Fractional excretion of sodium
Time frame: 6 weeks
Urinary excretion of aquaporin-2
Time frame: 6 weeks
Urinary excretion of ENaC-beta
Time frame: 6 weeks
Urinary excretion of NCC
Time frame: 6 weeks
Plasma concentration of aldosterone
Time frame: 6 weeks
Plasma concentration of angiotensin-II
Time frame: 6 weeks
Plasma concentration of ADH
Time frame: 6 weeks
Plasma concentration of atrial natriuretic peptide
Time frame: 6 weeks
Plasma concentration of brain natriuretic peptide
Time frame: 6 weeks
Plasma concentration of endothelin
Time frame: 6 weeks
24-hr ambulatory blood pressure
Time frame: 6 weeks
Central blood pressure
Time frame: 6 weeks
Pulse wave velocity
Time frame: 6 weeks
augmentation index
Time frame: 6 weeks
Plasma concentration of ionized calcium
Time frame: 6 weeks
Plasma concentration of phosphate
Time frame: 6 weeks
Plasma concentration of alkaline phosphatase
Time frame: 6 weeks
Plasma concentration of Parathyroid hormon
Time frame: 6 weeks
Plasma concentration of 25-hydroxy-vitamin D
Time frame: 6 weeks
Plasma concentration of ultrasensitive CRP
Time frame: 6 weeks
Plasma concentration of TNF-alpha
Time frame: 6 weeks
Plasma concentration of TGF-beta
Time frame: 6 weeks
Urinary excretion of calcium
Time frame: 6 weeks
Plasma concentration of ADMA
Time frame: 6 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 25 Jan 2012.
- Derived from this study: PubMed 23889806Larsen T, Mose FH, Bech JN, Pedersen EB. Effect of paricalcitol on renin and albuminuria in non-diabetic stage III-IV chronic kidney disease: a randomized placebo-controlled trial. BMC Nephrol. 2013 Jul 26;14:163. doi: 10.1186/1471-2369-14-163.
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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.
Erling B Pedersen, Prof, MSci principal investigator
Department of Medical Research
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 Zemplar in people with Chronic Kidney Disease, run by Erling Bjerregaard Pedersen 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 2 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 25 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 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. Some participants in this study may receive a placebo. 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?
plasma renin concentration (time frame: 6 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 NCT01136564, 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 25 Jan 2012.