Renal FailureNCT00466882
Use of the INAMED LAPBAND System to Reduce BMI's in Obese Renal Failure Patients
An observational study of Renal Failure and Obesity, run by Summa Health System at 1 site in United States.
Trial summary
The purpose of this study is to assess the use of this Lap-Band system for the purpose of promoting weight loss in renal failure patients who do not qualify as transplant candidates because of excessive BMI's Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Obesity
- What is being tested?
- Inamed Lap-Band System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2005to 24 Jan 2011
- Phase
- Observational
- 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
Study population: Patients with renal failure that have BMI's above 35 that would be a candidate for renal transplant if their BMI were 35 or less
Who may be able to join
- 18 or older
- Hemodialysis patient with BMI between 36 and 42
Who cannot join
- Patients undergoing peritoneal dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Issues Related to the Use of the INAMED LAPBAND SYSTEM to Reduce BMI's in Obese Renal Failure Patients Needing Renal Transplantation: A Pilot Study
The purpose of this study is to assess the use of this Lap-Band system for the purpose of promoting weight loss in renal failure patients who do not qualify as transplant candidates because of excessive BMI's
Read the detailed description
The concern of transplant surgeons is that obese patients with high BMI's are more likely to experience post-transplantation complications than age-matched recipients [1]. Nevertheless, the Summa transplant list contains numerous patients with renal failure that have BMI's above 35. These patients are not considered to be "active" transplant candidates because of their obesity and are not eligible to receive a kidney transplant. Dr. Lal counsels these patients that they must lose weight in order to be considered active candidates for transplantation.
Weight loss for obese patients in renal failure is difficult. These patients must undergo hemodialysis three times weekly. Most of these patients do not, or physically cannot, engage in exercise activities. Many of these patients are burdened psychologically, and further behavioral responsibilities related to weight loss may overstress them. Repetitive diets or behavioral therapy in morbidly obese patients prior to transplantation have had disappointing results [2]. Likewise, pharmacological management of obesity in these patients is largely unsuccessful. Noradrenergic appetite suppressants must be restricted because of stimulatory side-effects. Serotonergic agents have cardiovascular and pulmonary complications. Thermogenic agents are minimally effective [2].
The INAMED LAPBAND SYSTEM is an FDA-approved, surgically-placed device marketed to facilitate weight reduction in obese individuals. The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years. These adjustments are performed on average 4-5 times during the first year and twice during the second year.
The purpose of this pilot study is to assess the utility of the LAPBAND in facilitating weight loss in obese renal failure patients awaiting transplantation and to document issues related to its use in these patients. The hope is that the LAPBAND will facilitate enough weight loss to reduce the patient's BMI to 35 or below after placement of the LAPBAND. If the patient reaches the intended goal of BMI of 35, they will be placed on the active renal transplant list and will be eligible for transplantation.
A secondary goal of this research is to follow those patients who successfully reach BMI's of 35 or less who are subsequently transplanted to determine any untoward effects of the LAPBAND upon transplantation success
- Conditions
- Renal Failure, Obesity
- Being tested
- Inamed Lap-Band System
- Keywords
- obese, renal failure, renal transplant candidate, Hemodialysis BMI between 36 and 42
- Medical subject headings
- Renal Insufficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inamed Lap-Band SystemDevice
Patient's will be seen in the physician's office one week post surgery and once a month thereafter. The device can be gradually adjusted by the insertion of a needle into the port and saline is added or removed to inflate or deflate the LAPBAND. This can be conducted in the physician's office setting to enable the patient to lose 1-2 pounds per week over two years.
| Study group | Role | What they receive |
|---|---|---|
| Inamed Lap-Band System | The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years. Receives: Device: Inamed Lap-Band System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Assess weight loss after surgery
Measured: 2 years
Secondary outcomes (1)
Transplantation Success
Assess possible effects of weight loss surgery on transplantation success
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study start17 Oct 2005
- Primary completionNov 2010 (estimated)
- Study completion24 Jan 2011
Why it stopped: No patients were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Zografakis, Summa Health System
- Investigators
- John Zografakis, MD, Principal investigator, Summa Health SystemTanamay Lal, MD, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466882
- Sponsor's protocol ID
- INAMED
- Status last verified
- Nov 2018
- First submitted
- 26 Apr 2007
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Issues Related to the Use of the INAMED LAPBAND SYSTEM to Reduce BMI's in Obese Renal Failure Patients Needing Renal Transplantation: A Pilot Study
- ClinicalTrials.gov ID
- NCT00466882
- Acronym / sponsor ID
- INAMED
- Conditions
- Renal Failure, Obesity
- Keywords
- obese, renal failure, renal transplant candidate, Hemodialysis BMI between 36 and 42
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- 17 Oct 2005 (actual)
- Primary completion
- Nov 2010 (estimated)
- Study completion
- 24 Jan 2011 (actual)
- First posted
- 27 Apr 2007 (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 purpose of this study is to assess the use of this Lap-Band system for the purpose of promoting weight loss in renal failure patients who do not qualify as transplant candidates because of excessive BMI's
Detailed description
The concern of transplant surgeons is that obese patients with high BMI's are more likely to experience post-transplantation complications than age-matched recipients [1]. Nevertheless, the Summa transplant list contains numerous patients with renal failure that have BMI's above 35. These patients are not considered to be "active" transplant candidates because of their obesity and are not eligible to receive a kidney transplant. Dr. Lal counsels these patients that they must lose weight in order to be considered active candidates for transplantation.
Weight loss for obese patients in renal failure is difficult. These patients must undergo hemodialysis three times weekly. Most of these patients do not, or physically cannot, engage in exercise activities. Many of these patients are burdened psychologically, and further behavioral responsibilities related to weight loss may overstress them. Repetitive diets or behavioral therapy in morbidly obese patients prior to transplantation have had disappointing results [2]. Likewise, pharmacological management of obesity in these patients is largely unsuccessful. Noradrenergic appetite suppressants must be restricted because of stimulatory side-effects. Serotonergic agents have cardiovascular and pulmonary complications. Thermogenic agents are minimally effective [2].
The INAMED LAPBAND SYSTEM is an FDA-approved, surgically-placed device marketed to facilitate weight reduction in obese individuals. The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years. These adjustments are performed on average 4-5 times during the first year and twice during the second year.
The purpose of this pilot study is to assess the utility of the LAPBAND in facilitating weight loss in obese renal failure patients awaiting transplantation and to document issues related to its use in these patients. The hope is that the LAPBAND will facilitate enough weight loss to reduce the patient's BMI to 35 or below after placement of the LAPBAND. If the patient reaches the intended goal of BMI of 35, they will be placed on the active renal transplant list and will be eligible for transplantation.
A secondary goal of this research is to follow those patients who successfully reach BMI's of 35 or less who are subsequently transplanted to determine any untoward effects of the LAPBAND upon transplantation success
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inamed Lap-Band System | – | Device: Inamed Lap-Band SystemThe LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with renal failure that have BMI's above 35 that would be a candidate for renal transplant if their BMI were 35 or less
Key inclusion criteria (2 listed)
- 18 or older
- Hemodialysis patient with BMI between 36 and 42
Key exclusion criteria (1 listed)
- Patients undergoing peritoneal dialysis
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 |
|---|---|---|
| Inamed Lap-Band SystemPatient's will be seen in the physician's office one week post surgery and once a month thereafter. The device can be gradually adjusted by the insertion of a needle into the port and saline is added or removed to inflate or deflate the LAPBAND. This can be conducted in the physician's office setting to enable the patient to lose 1-2 pounds per week over two years. | Device | Inamed Lap-Band System |
Primary outcome
Weight Loss
Time frame: 2 years
Assess weight loss after surgery
1 secondary outcome
Transplantation Success
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
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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.
John Zografakis, MD principal investigator
Summa Health System
Tanamay Lal, MD principal investigator
Summa Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure and Obesity, run by Summa Health System at 1 site 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 30 Nov 2018. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Weight Loss (time frame: 2 years). 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 30 Nov 2018.