Disorder Related to Cardiac TransplantationPhase 4NOCTETNCT00377962
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
A Phase 4 study testing Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA) and Calcineurin inhibitors (CNI) in people with Disorder Related to Cardiac Transplantation, run by Novartis Pharmaceuticals at 6 sites in 3 countries.
Trial summary
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disorder Related to Cardiac Transplantation
- What is being tested?
- Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA) and Calcineurin inhibitors (CNI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Dec 2005to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone a heart or lung transplantation more than 12 months ago.
- Patients receiving Neoral® or Prograf®.
- Patients with a measured or calculated glomerular filtration rate (GFR) > 20 and < 70 mL/min/1.73m^2. For patients with a GFR > 60 and < 70 mL/min/1.73m^2, a deteriorated renal function since the time of transplantation must be documented by at least one post-transplant GFR level that is > 10% above the GFR level at the time of inclusion.
- Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months.
- Females of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
Who cannot join
- Patients who are recipients of multiple organ transplants.
- Patients with measured GFR < 20 mL/min/1.73m^2 or > 70 mL/min/1.73m^2.
- Patients with a treated acute rejection episode within the last 3 months.
- Patients with a platelet count of < 50,000/mm^3 or with a white blood cell count of ≤ 2,500/mm^3 or with a hemoglobin value < 8 g/dL.
- Presence of severe hypercholesterolemia (≥ 8.0 mmol/L) or hypertriglyceridemia (≥ 6.0 mmol/L) despite conventional lipid lowering treatment.
- Patients currently treated or who have been treated with a mammalian target of rapamycin (mTOR) inhibitor.
Show all 15Show fewer
- Patients who have received an investigational drug within 4 weeks.
- Patients who are human immunodeficiency virus positive or who have a current severe systemic infection requiring continued therapy according to investigator judgment.
- Present use of any immunosuppressive drugs other than Neoral®/Prograf®, mycophenolic acid/azathioprine (MPA/AZA), and/or steroids.
- Patients with a known hypersensitivity to drugs similar to everolimus.
- Symptoms of significant mental illness which, in the opinion of the investigator, may interfere with the patient's ability to comply with the protocol. History of drug or alcohol abuse within 1 year of baseline.
- Inability to cooperate or communicate with the investigator.
- Patients with any past (within the last 5 years) or present malignancy other than excised squamous or basal cell carcinoma.
- Females of childbearing potential that are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use effective means of contraception.
- Patients with a planned coronary revascularization or patients who have experienced a major adverse cardiovascular event (MACE) within the last 3 months.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Sweden3 sites
Novartis Investigative Site
Gothenburg, 413 45
Novartis Investigative Site
Linköping, 581 85
Novartis Investigative Site
Lund, 22185
Denmark2 sites
Novartis Investigative Site
Aarhus, DK-8200
Novartis Investigative Site
Copenhagen, 2100
About this study
Official title: Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation: Results at 24 Months
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
- Being tested
- Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA), Calcineurin inhibitors (CNI), Steroids
- Keywords
- thoracic transplant recipients, everolimus, immunosuppressants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican
0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.
Mycophenolic acid (MPA)/azathioprine (AZA)Drug
Also called Neoral®/Prograf®
In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.
Calcineurin inhibitors (CNI)Drug
Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.
SteroidsDrug
Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus + CNI reduction | Experimental | Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice. Receives: Drug: Everolimus; Drug: Calcineurin inhibitors (CNI); Drug: Steroids |
| Control | Active comparator | CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice. Receives: Drug: Mycophenolic acid (MPA)/azathioprine (AZA); Drug: Calcineurin inhibitors (CNI); Drug: Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12
Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.
Measured: Baseline to Month 12
Secondary outcomes (11)
Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)
Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.
Measured: Baseline to end of study (Month 24)
Change in Serum Creatinine From Baseline to End of Study (Month 24)
Renal function was assessed by determining serum creatinine using standard laboratory methods. A positive change score indicates improved renal function.
Measured: Baseline to end of study (Month 24)
Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)
Biopsy-proved acute rejection was defined as a treated acute rejection confirmed by biopsy, graded locally according to the International Society for Heart \& Lung Transplantation (ISHLT) criteria. A treated acute rejection was defined as an acute rejection clinically suspected, whether biopsy-proven or not, which had been treated and confirmed by the investigator according to the response to therapy.
Measured: Month 12 to end of study (Month 24)
Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)
Number of patients not alive and number of patients with loss of their graft.
Measured: Month 12 to end of study (Month 24)
Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)
Measured: Month 12 to end of study (Month 24)
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup
Forced expiratory volume in 1 second (FEV1) was measured by spirometry conducted according to internationally accepted standards. FEV1 is the volume delivered in the first second of a forced vital capacity (FVC) maneuver. A positive change score indicates improved lung function.
Measured: Baseline to end of study (Month 24)
Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup
Forced vital capacity (FVC) was measured by spirometry conducted according to internationally accepted standards. FVC is the volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration. A positive change score indicates improved lung function.
Measured: Baseline to end of study (Month 24)
Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup
Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), interventricular septal wall thickness (IVSTd), and posterior wall thickness (PWTd). A positive change score indicates improved left ventricular function.
Measured: Baseline to end of study (Month 24)
Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup
Left ventricular function was assessed by echocardiography which was performed according to local routine practice. Echocardiography parameters were filling fraction (FF) and ejection fraction (EF). A positive change score indicates improved left ventricular function.
Measured: Baseline to end of study (Month 24)
Mean Days of Hospitalization From Baseline to End of Study (Month 24)
Measured: Baseline to end of study (Month 24)
Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)
Measured: Month 12 to end of study (Month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2006 (estimated)
- Study startDec 2005
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disorder Related to Cardiac TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377962
- Sponsor's protocol ID
- CRAD001AIC01
- Acronym
- NOCTET
- Status last verified
- Jul 2020
- First submitted
- 15 Sep 2006
- Last updated
- 30 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Murbraech K, Tecklzig F, Massey RJ, Gude E, Gustafsson F, Eiskjaer H, Karason K, Radegran G, Andreassen AK, Gullestad L, Broch K. Development in Left Ventricular Mass After Early and Late Conversion From Calcineurin Inhibitors to Everolimus in Heart Transplant Recipients-Results From Two Randomized Controlled Trials. Clin Transplant. 2026 Oct;40(10):e70705. doi: 10.1111/ctr.70705.
PubMed 42853965Norum HM, Michelsen AE, Lekva T, Arora S, Otterdal K, Olsen MB, Kong XY, Gude E, Andreassen AK, Solbu D, Karason K, Dellgren G, Gullestad L, Aukrust P, Ueland T. Circulating delta-like Notch ligand 1 is correlated with cardiac allograft vasculopathy and suppressed in heart transplant recipients on everolimus-based immunosuppression. Am J Transplant. 2019 Apr;19(4):1050-1060. doi: 10.1111/ajt.15141. Epub 2018 Nov 5.
PubMed 30312541Arora S, Erikstad I, Ueland T, Sigurdardottir V, Ekmehag B, Jansson K, Eiskjaer H, Botker HE, Mortensen SA, Saunamaki K, Gude E, Ragnarsson A, Solbu D, Aukrust P, Gullestad L. Virtual histology assessment of cardiac allograft vasculopathy following introduction of everolimus--results of a multicenter trial. Am J Transplant. 2012 Oct;12(10):2700-9. doi: 10.1111/j.1600-6143.2012.04234.x. Epub 2012 Sep 7.
PubMed 22958738Arora S, Gude E, Sigurdardottir V, Mortensen SA, Eiskjaer H, Riise G, Mared L, Bjortuft O, Ekmehag B, Jansson K, Simonsen S, Aukrust P, Solbu D, Iversen M, Gullestad L. Improvement in renal function after everolimus introduction and calcineurin inhibitor reduction in maintenance thoracic transplant recipients: the significance of baseline glomerular filtration rate. J Heart Lung Transplant. 2012 Mar;31(3):259-65. doi: 10.1016/j.healun.2011.12.010.
PubMed 22333403
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation: Results at 24 Months
- ClinicalTrials.gov ID
- NCT00377962
- Acronym / sponsor ID
- NOCTET / CRAD001AIC01
- Keywords
- thoracic transplant recipients, everolimus, immunosuppressants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Sep 2006 (estimated)
- Results
- Posted 18 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus + CNI reduction | Experimental | Drug: Everolimus, Drug: Calcineurin inhibitors (CNI), Drug: SteroidsEverolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice. |
| Control | Active comparator | Drug: Mycophenolic acid (MPA)/azathioprine (AZA), Drug: Calcineurin inhibitors (CNI), Drug: SteroidsCNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have undergone a heart or lung transplantation more than 12 months ago.
- Patients receiving Neoral® or Prograf®.
- Patients with a measured or calculated glomerular filtration rate (GFR) > 20 and < 70 mL/min/1.73m^2. For patients with a GFR > 60 and < 70 mL/min/1.73m^2, a deteriorated renal function since the time of transplantation must be documented by at least one post-transplant GFR level that is > 10% above the GFR level at the time of inclusion.
- Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months.
- Females of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
Key exclusion criteria (15 listed)
- Patients who are recipients of multiple organ transplants.
- Patients with measured GFR < 20 mL/min/1.73m^2 or > 70 mL/min/1.73m^2.
- Patients with a treated acute rejection episode within the last 3 months.
- Patients with a platelet count of < 50,000/mm^3 or with a white blood cell count of ≤ 2,500/mm^3 or with a hemoglobin value < 8 g/dL.
- Presence of severe hypercholesterolemia (≥ 8.0 mmol/L) or hypertriglyceridemia (≥ 6.0 mmol/L) despite conventional lipid lowering treatment.
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 |
|---|---|---|
| EverolimusAlso: Certican0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL. | Drug | Everolimus + CNI reduction |
| Mycophenolic acid (MPA)/azathioprine (AZA)Also: Neoral®/Prograf®In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice. | Drug | Control |
| Calcineurin inhibitors (CNI)Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus. | Drug | Control, Everolimus + CNI reduction |
| SteroidsSteroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change. | Drug | Control, Everolimus + CNI reduction |
Primary outcome
Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12
Time frame: Baseline to Month 12
Renal function was assessed by determining the measured glomerular filtration rate (mGFR) using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. A positive change score indicates improved renal function.
11 secondary outcomes
Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to End of Study (Month 24)
Time frame: Baseline to end of study (Month 24)
Change in Serum Creatinine From Baseline to End of Study (Month 24)
Time frame: Baseline to end of study (Month 24)
Number of Patients With Biopsy-proven Acute Rejection From Month 12 to End of Study (Month 24)
Time frame: Month 12 to end of study (Month 24)
Number of Patients Who Died and Number of Patients With Graft Loss From Month 12 to End of Study (Month 24)
Time frame: Month 12 to end of study (Month 24)
Number of Patients in Need of Dialysis From Month 12 to End of Study (Month 24)
Time frame: Month 12 to end of study (Month 24)
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup
Time frame: Baseline to end of study (Month 24)
Change in Forced Vital Capacity (FVC) From Baseline to End of Study (Month 24) in the Lung Transplant Subgroup
Time frame: Baseline to end of study (Month 24)
Change in Left Ventricular Function (Diameter and Thickness Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup
Time frame: Baseline to end of study (Month 24)
Change in Left Ventricular Function (Filling and Ejection Fraction Parameters) From Baseline to End of Study (Month 24) in the Heart Transplant Subgroup
Time frame: Baseline to end of study (Month 24)
Mean Days of Hospitalization From Baseline to End of Study (Month 24)
Time frame: Baseline to end of study (Month 24)
Number of Patients Discontinued From the Study Due to Adverse Events From Month 12 to End of Study (Month 24)
Time frame: Month 12 to end of study (Month 24)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42853965Murbraech K, Tecklzig F, Massey RJ, Gude E, Gustafsson F, Eiskjaer H, Karason K, Radegran G, Andreassen AK, Gullestad L, Broch K. Development in Left Ventricular Mass After Early and Late Conversion From Calcineurin Inhibitors to Everolimus in Heart Transplant Recipients-Results From Two Randomized Controlled Trials. Clin Transplant. 2026 Oct;40(10):e70705. doi: 10.1111/ctr.70705.
- Derived from this study: PubMed 30312541Norum HM, Michelsen AE, Lekva T, Arora S, Otterdal K, Olsen MB, Kong XY, Gude E, Andreassen AK, Solbu D, Karason K, Dellgren G, Gullestad L, Aukrust P, Ueland T. Circulating delta-like Notch ligand 1 is correlated with cardiac allograft vasculopathy and suppressed in heart transplant recipients on everolimus-based immunosuppression. Am J Transplant. 2019 Apr;19(4):1050-1060. doi: 10.1111/ajt.15141. Epub 2018 Nov 5.
- Derived from this study: PubMed 22958738Arora S, Erikstad I, Ueland T, Sigurdardottir V, Ekmehag B, Jansson K, Eiskjaer H, Botker HE, Mortensen SA, Saunamaki K, Gude E, Ragnarsson A, Solbu D, Aukrust P, Gullestad L. Virtual histology assessment of cardiac allograft vasculopathy following introduction of everolimus--results of a multicenter trial. Am J Transplant. 2012 Oct;12(10):2700-9. doi: 10.1111/j.1600-6143.2012.04234.x. Epub 2012 Sep 7.
- Derived from this study: PubMed 22333403Arora S, Gude E, Sigurdardottir V, Mortensen SA, Eiskjaer H, Riise G, Mared L, Bjortuft O, Ekmehag B, Jansson K, Simonsen S, Aukrust P, Solbu D, Iversen M, Gullestad L. Improvement in renal function after everolimus introduction and calcineurin inhibitor reduction in maintenance thoracic transplant recipients: the significance of baseline glomerular filtration rate. J Heart Lung Transplant. 2012 Mar;31(3):259-65. doi: 10.1016/j.healun.2011.12.010.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus, Mycophenolic acid (MPA)/azathioprine (AZA) and Calcineurin inhibitors (CNI) in people with Disorder Related to Cardiac Transplantation, run by Novartis Pharmaceuticals at 6 sites in 3 countries.
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 15 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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, Denmark, Norway. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12 (time frame: Baseline to Month 12). 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 NCT00377962, which also lists 4 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 30 Jul 2020.