Transplant; Failure, KidneyNCT01441570
The Impact of Nebivolol Versus Metoprolol on Quality of Life
A study testing Nebivolol and Metoprolol succinate in people with Transplant; Failure, Kidney and Hypertension, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
In an open label analysis, nebivolol has been shown to have a positive impact on quality of life in the general hypertensive population. That is, patients treated with nebivolol reported less side effects compared to those treated with metoprolol. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplant; Failure, Kidney, Hypertension
- What is being tested?
- Nebivolol and Metoprolol succinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Jul 2013
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult renal transplant recipients, men and women between 18 and 75 years of age, inclusive.
- Patients must be > 3 months post-transplant.
- Patients must have stable renal function (stable renal function will be defined as those patients without infection or hospitalization [for any reason] over the past 30 days, and patients with < 20% change in their serum creatinine over the past 30 days.
- Patients receiving corticosteroids must be receiving a daily dose of < 7.5 mg of prednisone (or therapeutic equivalents based on glucocorticoid equivalency scale).
- All eligible patients must be receiving antihypertensive medication management which must include metoprolol tartrate or metoprolol succinate.
- Patients may be on more than one medication to control their hypertension. Use of any other FDA-approved antihypertensive agent is permitted.
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- All eligible patients will either be at goal blood pressure (<120/80 mmHg) or have Pre-hypertension (<140/90 mmHg) or Stage I hypertension (<160/100 mmHg) at the time of study inclusion.
- Patients who are able to comprehend and satisfactorily comply with protocol requirements.
- Patients who signed the written informed consent given prior to entering any study procedure.
Who cannot join
- Patients with Stage II/uncontrolled hypertension (>159/99 mmHg).
- Patients with an easily identifiable etiology for fatigue (i.e. anemia, iron-deficiency, poor sleep patterns, etc.).
- Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial (i.e. arrhythmia).
- Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, hepatic, gastrointestinal or neurological disease (including any form of epilepsy). If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
- Patients who are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
- Patients with any contraindications to beta blocker therapy as listed in the package labeling for both metoprolol succinate and nebivolol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Lahey Clinic
Burlington, Massachusetts, 01805
About this study
Official title: The Impact of Nebivolol Versus Metoprolol on Quality of Life Measures and Cost-effectiveness in Stable Renal Transplant Recipients
In an open label analysis, nebivolol has been shown to have a positive impact on quality of life in the general hypertensive population. That is, patients treated with nebivolol reported less side effects compared to those treated with metoprolol. Also, more nebivolol treated patients reached normalization of blood pressure. Although there is no data, it is believed that the impact would be similar in renal transplant recipients.
The primary goal of this study is to determine if nebivolol will improve the quality of life measurements of kidney transplant recipients as compared to those treated with metoprolol succinate. This will be measured by comparing the scores of four quality of life questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of this study are to determine if the use of nebivolol is cost-effective in the renal transplant recipient; determine if there is a change in urine protein excretion and renal function with the use of nebivolol; and determine the number of patients that maintain or achieve a target blood pressure of ≤ 120/80 mmHg.
- Conditions
- Transplant; Failure, Kidney, Hypertension
- Being tested
- Nebivolol, Metoprolol succinate
- Keywords
- kidney, transplant, hypertension, nebivolol, metoprolol, bystolic, toprol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
Also called Bystolic
Subject will take nebivolol daily for 12 weeks.
Metoprolol succinateDrug
Also called Toprol XL
Subject will take metoprolol succinate daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol | Active comparator | Not described Receives: Drug: Nebivolol |
| Metoprolol Succinate | Active comparator | Not described Receives: Drug: Metoprolol succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires. The four quality of life questionnaires that were used included the following:
- Short Form (SF)-36v2 Health Survey (Score Range = 0-100; the lower the score the more disability)
- Sexual Dysfunction Tool for Men = International Index of Erectile Function (IIEF) Questionnaire (Score Range = 5-25; a score of 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction)
- Sexual Dysfunction Tool for Women = Changes in Sexual Functioning Questionnaire (CSFQ-14-F; Score Range = 14-70; a score at or below 42 is indicative of sexual dysfunction)
- Multidimensional Assessment of Fatigue (MAF) Scale (Score Range = 1-50; the higher the score the more fatigue)
Measured: 12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 - End of week 12)
Secondary outcomes (1)
Blood Pressure
Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startFeb 2012
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: due to slow enrollment
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.
- Other trials for Transplant; Failure, KidneyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories, Lahey Clinic
- Responsible party
- Principal investigator, Steven Gabardi, Brigham and Women's Hospital
- Investigators
- Steven Gabardi, PharmD, FCCP, BCPS, Principal investigator, Transplant Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441570
- Sponsor's protocol ID
- 2011P001638
- Status last verified
- Mar 2017
- First submitted
- 26 Sep 2011
- Last updated
- 20 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nebivolol Versus Metoprolol on Quality of Life Measures and Cost-effectiveness in Stable Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01441570
- Acronym / sponsor ID
- 2011P001638
- Conditions
- Transplant; Failure, Kidney, Hypertension
- Keywords
- kidney, transplant, hypertension, nebivolol, metoprolol, bystolic, toprol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Forest Laboratories, Lahey Clinic
- Study start
- Feb 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Posted 20 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In an open label analysis, nebivolol has been shown to have a positive impact on quality of life in the general hypertensive population. That is, patients treated with nebivolol reported less side effects compared to those treated with metoprolol. Also, more nebivolol treated patients reached normalization of blood pressure. Although there is no data, it is believed that the impact would be similar in renal transplant recipients.
The primary goal of this study is to determine if nebivolol will improve the quality of life measurements of kidney transplant recipients as compared to those treated with metoprolol succinate. This will be measured by comparing the scores of four quality of life questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of this study are to determine if the use of nebivolol is cost-effective in the renal transplant recipient; determine if there is a change in urine protein excretion and renal function with the use of nebivolol; and determine the number of patients that maintain or achieve a target blood pressure of ≤ 120/80 mmHg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebivolol | Active comparator | Drug: Nebivolol |
| Metoprolol Succinate | Active comparator | Drug: Metoprolol succinate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult renal transplant recipients, men and women between 18 and 75 years of age, inclusive.
- Patients must be > 3 months post-transplant.
- Patients must have stable renal function (stable renal function will be defined as those patients without infection or hospitalization [for any reason] over the past 30 days, and patients with < 20% change in their serum creatinine over the past 30 days.
- Patients receiving corticosteroids must be receiving a daily dose of < 7.5 mg of prednisone (or therapeutic equivalents based on glucocorticoid equivalency scale).
- All eligible patients must be receiving antihypertensive medication management which must include metoprolol tartrate or metoprolol succinate.
Key exclusion criteria (6 listed)
- Patients with Stage II/uncontrolled hypertension (>159/99 mmHg).
- Patients with an easily identifiable etiology for fatigue (i.e. anemia, iron-deficiency, poor sleep patterns, etc.).
- Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial (i.e. arrhythmia).
- Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, hepatic, gastrointestinal or neurological disease (including any form of epilepsy). If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
- Patients who are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
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 |
|---|---|---|
| NebivololAlso: BystolicSubject will take nebivolol daily for 12 weeks. | Drug | Nebivolol |
| Metoprolol succinateAlso: Toprol XLSubject will take metoprolol succinate daily for 12 weeks. | Drug | Metoprolol Succinate |
Primary outcome
Quality of Life
Time frame: 12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 - End of week 12)
Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires. The four quality of life questionnaires that were used included the following: 1. Short Form (SF)-36v2 Health Survey (Score Range = 0-100; the lower the score the more disability) 2. Sexual Dysfunction Tool for Men = International Index of Erectile Function (IIEF) Questionnaire (Score Range = 5-25; a score of 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction) 3. Sexual Dysfunction Tool for Women = Changes in Sexual Functioning Questionnaire (CSFQ-14-F; Score Range = 14-70; a score at or below 42 is indicative of sexual dysfunction) 4. Multidimensional Assessment of Fatigue (MAF) Scale (Score Range = 1-50; the higher the score the more fatigue)
1 secondary outcome
Blood Pressure
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven Gabardi, PharmD, FCCP, BCPS principal investigator
Transplant Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebivolol and Metoprolol succinate in people with Transplant; Failure, Kidney and Hypertension, run by Brigham and Women's Hospital at 2 sites in United States.
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 9 inclusion and 6 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2017). 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?
Quality of Life (time frame: 12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 - End of week 12)). 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 20 Apr 2017.