NephropathyPhase 2STADNCT01208701
The Effects of Atorvastatin on the Nitrogen Oxide-system in Patients With Type 2 Diabetes and Nephropathy
A Phase 2 study testing Atorvastatin and Unikalk in people with Nephropathy and Cardiovascular Diseases, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial summary
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Nephropathy, Cardiovascular Diseases, Diabetes Mellitus
- What is being tested?
- Atorvastatin and Unikalk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- May 2010to Jan 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- minimum 40 years
- Chronic Kidney disease
- Estimated GFR (eGFR) between 30 and 90 ml/min
- Diabetes Mellitus type II
Who cannot join
- Nephrotic Syndrome
- Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease
- Neoplastic disease
- Alcohol abuse,
- Drug abuse
- Pregnancy or nursing
- Blood donation within a month before examination
- Hgb < 6,0
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medicinsk Forskning, Regionshospitalet Holstebro
Holstebro, 7500
About this study
Official title: The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients with type 2 diabetes with nephropathy.
Read the detailed description
Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.
On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.
Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC) will be measured to evaluate channel activity in the nephron.
Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.
- Conditions
- Nephropathy, Cardiovascular Diseases, Diabetes Mellitus
- Being tested
- Atorvastatin, Unikalk
- Keywords
- Atorvastatin, L-NMMA, NO, Nephrology, Diabetes Mellitus
- Medical subject headings
- Kidney Diseases, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Zarator
Zarator, 80 mg pr day for 5 days
UnikalkDrug
1 tablet Unikalk pr day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Unikalk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional excretion of sodium
Measured: 5 days treatment
Secondary outcomes (6)
Systolic blood pressure
Measured: 5 days
Plasma renin concentration
Measured: 5 days
Arterial stiffness
Measured: 5 days
Plasma angiotensin II concentration
Measured: 5 days
Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)
Measured: 5 days
Augmentations index
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NephropathyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 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
- Frank H Christensen, MD, Principal investigator, Department of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208701
- Sponsor's protocol ID
- EBP-FHC-2010-3
- Acronym
- STAD
- Status last verified
- Aug 2015
- First submitted
- 19 Sep 2010
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
PubMed 38018702Mose FH, Larsen T, Jensen JM, Hansen AB, Bech JN, Pedersen EB. Effect of atorvastatin on renal NO availability and tubular function in patients with stage II-III chronic kidney disease and type 2 diabetes. Scand J Clin Lab Invest. 2014 Jan;74(1):8-19. doi: 10.3109/00365513.2013.855942. Epub 2013 Nov 21.
PubMed 24256611
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Atorvastatin on the NO-system in Patients With Type 2 Diabetes and Nephropathy
- ClinicalTrials.gov ID
- NCT01208701
- Acronym / sponsor ID
- STAD / EBP-FHC-2010-3
- Conditions
- Nephropathy, Cardiovascular Diseases, Diabetes Mellitus
- Keywords
- Atorvastatin, L-NMMA, NO, Nephrology, Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Sep 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.
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in patients with type 2 diabetes with nephropathy.
Detailed description
Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.
On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.
Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC) will be measured to evaluate channel activity in the nephron.
Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Active comparator | Drug: Atorvastatin |
| Placebo | Placebo comparator | Drug: Unikalk |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women
- minimum 40 years
- Chronic Kidney disease
- Estimated GFR (eGFR) between 30 and 90 ml/min
- Diabetes Mellitus type II
Key exclusion criteria (8 listed)
- Nephrotic Syndrome
- Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease
- Neoplastic disease
- Alcohol abuse,
- Drug abuse
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 |
|---|---|---|
| AtorvastatinAlso: ZaratorZarator, 80 mg pr day for 5 days | Drug | Atorvastatin |
| Unikalk1 tablet Unikalk pr day for 5 days | Drug | Placebo |
Primary outcome
Fractional excretion of sodium
Time frame: 5 days treatment
6 secondary outcomes
Systolic blood pressure
Time frame: 5 days
Plasma renin concentration
Time frame: 5 days
Arterial stiffness
Time frame: 5 days
Plasma angiotensin II concentration
Time frame: 5 days
Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)
Time frame: 5 days
Augmentations index
Time frame: 5 days
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 21 Aug 2015.
- Derived from this study: PubMed 38018702Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
- Derived from this study: PubMed 24256611Mose FH, Larsen T, Jensen JM, Hansen AB, Bech JN, Pedersen EB. Effect of atorvastatin on renal NO availability and tubular function in patients with stage II-III chronic kidney disease and type 2 diabetes. Scand J Clin Lab Invest. 2014 Jan;74(1):8-19. doi: 10.3109/00365513.2013.855942. Epub 2013 Nov 21.
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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.
Frank H Christensen, MD 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 Atorvastatin and Unikalk in people with Nephropathy and Cardiovascular Diseases, 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 5 inclusion and 8 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 21 Aug 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. 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?
Fractional excretion of sodium (time frame: 5 days treatment). 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 NCT01208701, which also lists 2 linked publications.
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 21 Aug 2015; AzTrials last refreshed its copy on 7 Nov 2026.