Cardiovascular DiseasePhase 4NCT01331317
Effect of a Vitamin D Analogue vs Placebo on p-NT-proBNP in Patients With Type 1 DM and Diabetic Nephropathy
A Phase 4 study testing Paricalcitol in people with Cardiovascular Disease and Diabetic Nephropathy, run by Peter Rossing at 1 site in Denmark.
Trial summary
The primary objective is to assess the impact of three months of treatment with an active vitamin D analogue on a risk marker for excess overall mortality and cardiovascular morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Disease, Diabetic Nephropathy
- What is being tested?
- Paricalcitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Apr 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- Type 1 diabetes mellitus
- Diabetic nephropathy (defined by persistent albuminuria, > 300 mg/24 hr or 200µg/min in 2 of 3 consecutive samples, presence of diabetic retinopathy and absence of clinical or laboratory evidence of other kidney or renal tract disease
- Chronic kidney disease stage 3 and 4
- S-Parathyroid hormone (s-PTH)> 35pg/ml
- Stabile RAAS-blocking and diuretic treatment
Who cannot join
- Other kidney disease than diabetic nephropathy
- Myocardial infarction within the last three months prior to visit 1
- Coronary artery revascularization within the last three months prior to visit 1
- Transitional cerebral ischemia (TCI) or apoplexia within the last three months prior to visit 1
- Cardiac Failure (NYHA Class III or IV)
- Kidney Failure (GFR <15ml/min), dialysis, kidney transplantation)
Show all 17Show fewer
- Liver disease with serum alanine aminotransferase (ALT>3 x the normal value
- Alcohol/drug abuse
- Hypercalcemia (serum ionized calcium >1.35 mmol /L)
- Medication with phosphate and/or vitamin D-containing medications, which can not be paused during the study
- Clinical signs of vitamin D toxicity
- Pregnant or nursing women
- Fertile women not using chemical or mechanical (IUD) contraceptive methods
- Current disulfiram treatment
- Allergy to the study drug
- Patient unable to understand the informed consent
- Any other condition or therapy which, in the opinion of the investigator, makes the patient not suited for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Paricalcitol Versus Placebo on Plasma N-Terminal-proBNP in Patients With Type 1 Diabetes Mellitus and Diabetic Nephropathy
The primary objective is to assess the impact of three months of treatment with an active vitamin D analogue on a risk marker for excess overall mortality and cardiovascular morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and mortality in patients with type 1 diabetic kidney disease.
- Conditions
- Cardiovascular Disease, Diabetic Nephropathy
- Being tested
- Paricalcitol
- Keywords
- Cardiovascular disease and mortality, Plasma NTproBNP, UAER
- Medical subject headings
- Cardiovascular Diseases, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Also called Zemplar
capsule, 1-2 micrograms daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Other | Crossover study between paricalcitol and placebo Receives: Drug: Paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma NT-proBNP
Measured: 7 months
Secondary outcomes (2)
Change in Glomerular Filtration Rate (GFR)
Measured: 7 months
Change in Urinary Albumin Excretion Rate
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startApr 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Rossing
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- Lise Tarnow, MD, Principal investigator, Steno Diabetes Center A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331317
- Sponsor's protocol ID
- 2009-011255-44
- Other IDs
- 2009
- Status last verified
- Apr 2012
- First submitted
- 27 Jul 2010
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Paricalcitol Versus Placebo on Plasma N-Terminal-proBNP in Patients With Type 1 Diabetes Mellitus and Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01331317
- Acronym / sponsor ID
- 2009-011255-44
- Conditions
- Cardiovascular Disease, Diabetic Nephropathy
- Keywords
- Cardiovascular disease and mortality, Plasma NTproBNP, UAER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Peter RossingUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Apr 2011 (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 primary objective is to assess the impact of three months of treatment with an active vitamin D analogue on a risk marker for excess overall mortality and cardiovascular morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and mortality in patients with type 1 diabetic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol | Other | Drug: ParicalcitolCrossover study between paricalcitol and placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-75 years of age
- Type 1 diabetes mellitus
- Diabetic nephropathy (defined by persistent albuminuria, > 300 mg/24 hr or 200µg/min in 2 of 3 consecutive samples, presence of diabetic retinopathy and absence of clinical or laboratory evidence of other kidney or renal tract disease
- Chronic kidney disease stage 3 and 4
- S-Parathyroid hormone (s-PTH)> 35pg/ml
Key exclusion criteria (17 listed)
- Other kidney disease than diabetic nephropathy
- Myocardial infarction within the last three months prior to visit 1
- Coronary artery revascularization within the last three months prior to visit 1
- Transitional cerebral ischemia (TCI) or apoplexia within the last three months prior to visit 1
- Cardiac Failure (NYHA Class III or IV)
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: Zemplarcapsule, 1-2 micrograms daily for 90 days | Drug | Paricalcitol |
Primary outcome
Change in plasma NT-proBNP
Time frame: 7 months
2 secondary outcomes
Change in Glomerular Filtration Rate (GFR)
Time frame: 7 months
Change in Urinary Albumin Excretion Rate
Time frame: 7 months
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 13 Apr 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.
Lise Tarnow, MD principal investigator
Steno Diabetes Center A/S
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 Paricalcitol in people with Cardiovascular Disease and Diabetic Nephropathy, run by Peter Rossing 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 17 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 13 Apr 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. 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 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?
Change in plasma NT-proBNP (time frame: 7 months). 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 13 Apr 2012.