Bariatric SurgeryBARICADENCT05240443
Bariatric Surgery and Chronic Renal Disease
A study testing Bariatric Surgery + Medical Management of CKD. and Medical Management for CKD in people with Bariatric Surgery and Chronic Kidney Diseases, run by McMaster University at 1 site in Canada.
Trial summary
Obesity can be a major driver for the development of chronic kidney disease (CKD), which is a leading cause of death and significant loss in quality of life. A growing body of evidence has shown bariatric (metabolic) surgery as a novel approach to reduce the progression of CKD and reduce morbidity with sustained… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery, Chronic Kidney Diseases, Obesity
- What is being tested?
- Bariatric Surgery + Medical Management of CKD. and Medical Management for CKD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 1 Jun 2023
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age >18
- Body mass index > 40 (or > 35 kg/m2 for patients with comorbidities)
- Diagnosis of CKD stage III (G3a or A2) defined as the presence of any of the following:
- glomerular filtration rate (GFR) under 60 mL/min/1.73 m2 as estimated from serum creatinine or cystatin C with the CKD-EPI equation
- ACR > 30 mg/g
- Patient is deemed eligible to undergo bariatric surgery according to Ontario Bariatric Network (OBN) guidelines [contradictions to OBN guidelines include non-Ontario resident, age >70 years, history of cancer <2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites <1 year]
Who cannot join
- Hospital admission for kidney failure or acute kidney injury within 30 days of enrollment
- Documented GFR > 60 mL/min/1.73 m2 or ACR < 30 mg/g within 30 days of enrollment
- Documented confounders of kidney function measurement such as urinary tract infection or use of creatinine elevating medications or use of medications which interfere with measurement
- Contradiction to OBN guidelines including non-Ontario resident, age >70 years, history of cancer <2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites <1 year
- Life expectancy <2 years due to non-CKD causes OR Untreated or inadequately treated psychiatric illness OR Risk of general anesthesia deemed too excessive OR Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Yung Lee, MD, 4167327306, yung.lee@medportal.ca
Dennis Hong, MD, 9055221155 ext. 35148, dennishong70@gmail.com
About this study
Official title: Effect of Bariatric Surgery on Chronic Renal Disease (BARICADE): A Pilot Randomized Controlled Trial
Obesity can be a major driver for the development of chronic kidney disease (CKD), which is a leading cause of death and significant loss in quality of life. A growing body of evidence has shown bariatric (metabolic) surgery as a novel approach to reduce the progression of CKD and reduce morbidity with sustained weight loss. This pilot trial will inform the design and execution of a large RCT that could determine the efficacy of bariatric surgery in the treatment of patients with CKD in the context of obesity. Ultimately, the results have the potential to influence guidelines that may deem bariatric surgery as a viable treatment option for CKD and reduce the morbidity from this chronic condition and inform clinical practice.
Read the detailed description
Obesity is a major driver for the development of CKD, which is a leading cause of death and greatly reduces one's quality of life. With a global prevalence of 9.1% (7.2% in Canada), CKD affects an estimated 13.6% of the American population and was associated with over $50 billion in healthcare costs, with an additional $30 billion in costs associated with end-stage renal disease (ESRD). Moreover, with an aging Canadian population, the prevalence of CKD is expected to rise over the coming years with patients progressing to higher disease burdens. This, in part, has led to a substantial increase in renal replacement therapy by means of dialysis or kidney transplant by 43.1% since 1990. Obesity is also an important modulatory factor in the development of poor outcomes as a result of CKD and has been linked to an increased rate of progression from CKD towards kidney failure. The most common comorbidities in patients with CKD were hypertension, diabetes, heart failure, chronic pulmonary disease, and atrial fibrillation and in Canada, 25% of patients with CKD have at least 3 or more comorbidities which too are associated with an increased risk of hospitalization and early death. Most worryingly, unlike other non-communicable diseases today, the age-standardized mortality for CKD has not declined over the past decades. Therefore, innovative strategies are of timely importance to reduce mortality and morbidity in patients with CKD and thus urgently needed, especially in patients with multiple comorbidities and targeting weight loss is a promising avenue to find novel treatment options.
Bariatric surgery has been shown to not only facilitate sustained weight loss in patients with obesity, but also independently improve cardiac risk factors such as dyslipidemia, hypertension, and type 2 diabetes mellitus. It has also been shown to reverse glomerular hyperfiltration and lower proteinuria in patients with obesity and normal kidney function and delay the need for renal transplantation in patients with ESRD. Moreover, the protective benefit of bariatric surgery has been shown to reduce risk of CKD progression for up to seven years after intervention in observational studies. However, current guidelines do not address a role for bariatric surgery in the management of patients with obesity and CKD.
Given the poor outcomes with patients with obesity and CKD, a RCT to assess the efficacy and safety of bariatric surgery as an intervention for patients with CKD is of timely importance. The present proposed pilot RCT of bariatric surgery versus medical management alone for patients with morbid obesity and CKD in order to assess whether a large, multi-centre, efficacy trial is feasible. The results of the proposed pilot study will thus inform the design of a larger RCT in this patient population.
- Conditions
- Bariatric Surgery, Chronic Kidney Diseases, Obesity
- Being tested
- Bariatric Surgery + Medical Management of CKD., Medical Management for CKD
- Keywords
- Bariatric Surgery, Chronic Kidney Disease, Obesity
- Medical subject headings
- Renal Insufficiency, Chronic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric Surgery + Medical Management of CKD.Procedure or surgery
The intervention group will include medical management and bariatric surgery, which will consist of Roux-en-Y gastric bypass or sleeve gastrectomy performed according to local practice standards. Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD.
Medical Management for CKDOther
Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery + Medical Management for Chronic Kidney Disease | Experimental | The intervention group will include medical management and bariatric surgery, which will consist of Roux-en-Y gastric bypass or sleeve gastrectomy performed according to local practice standards. Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD. Receives: Procedure: Bariatric Surgery + Medical Management of CKD. |
| Medical Management for Chronic Kidney Disease | Active comparator | Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD. Receives: Other: Medical Management for CKD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months
Measured: Month 6
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 12 months
Measured: Month 12
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 18 months
Measured: Month 18
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months
Measured: Month 6
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 12 months
Measured: Month 12
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 18 months
Measured: Month 18
Creatine Clearance (units: mL/min) at 6 months
Measured: Month 6
Creatine Clearance (units: mL/min) at 12 months
Measured: Month 12
Creatine Clearance (units: mL/min) at 18 months
Measured: Month 18
Serum Creatinine (units: μmol/L) at 6 months
Measured: Month 6
Serum Creatinine (units: μmol/L) at 12 months
Measured: Month 12
Serum Creatinine (units: μmol/L) at 18 months
Measured: Month 18
Serum Cystatin C (units: mg/L) at 6 months
Measured: Month 6
Serum Cystatin C (units: mg/L) at 12 months
Measured: Month 12
Serum Cystatin C (units: mg/L) at 18 months
Measured: Month 18
Urine Albumin-Creatine Ratio (units: mg/g) at 6 months
Measured: Month 6
Urine Albumin-Creatine Ratio (units: mg/g) at 12 months
Measured: Month 12
Urine Albumin-Creatine Ratio (units: mg/g) at 18 months
Measured: Month 18
Secondary outcomes (7)
Weight and height will be combined to report BMI in kg/m^2 at 6 months
Measured: Month 6
Weight and height will be combined to report BMI in kg/m^2 at 12 months
Measured: Month 12
Weight and height will be combined to report BMI in kg/m^2 at 18 months
Measured: Month 18
Recruitment Rate (60 patients will be recruited at an average recruitment rate of 1.25 patients per site per month.)
60 patients will be recruited at an average recruitment rate of 1.25 patients per site per month.
Measured: Month 6
Intervention Administration Rate
>80% of patients randomized to the intervention arm will undergo bariatric surgery within 30 days of randomization.
Measured: Month 6
Crossover rate between control and intervention arm
Measured: Month 6
Number of patients adhering to study treatments
Patients will be monitored and asked about adherence at follow-ups.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Model description
- Single-centre, open-label, parallel-arm feasibility randomized controlled trial with blinded endpoint assessment.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Surgeons, McMaster Surgical Associates
- Responsible party
- Principal investigator, Dennis Hong MD, McMaster University
- Investigators
- Dennis Hong, MD MSc FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240443
- Sponsor's protocol ID
- 2022-14388-GRA
- Acronym
- BARICADE
- Status last verified
- Feb 2022
- First submitted
- 17 Jan 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.
PubMed 28236831Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
PubMed 17986697Bello AK, Ronksley PE, Tangri N, Kurzawa J, Osman MA, Singer A, Grill A, Nitsch D, Queenan JA, Wick J, Lindeman C, Soos B, Tuot DS, Shojai S, Brimble S, Mangin D, Drummond N. Prevalence and Demographics of CKD in Canadian Primary Care Practices: A Cross-sectional Study. Kidney Int Rep. 2019 Jan 21;4(4):561-570. doi: 10.1016/j.ekir.2019.01.005. eCollection 2019 Apr.
PubMed 30993231GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
PubMed 32061315Eknoyan G. Obesity and chronic kidney disease. Nefrologia. 2011;31(4):397-403. doi: 10.3265/Nefrologia.pre2011.May.10963. Epub 2011 May 30.
PubMed 21623393Tonelli M, Wiebe N, Guthrie B, James MT, Quan H, Fortin M, Klarenbach SW, Sargious P, Straus S, Lewanczuk R, Ronksley PE, Manns BJ, Hemmelgarn BR. Comorbidity as a driver of adverse outcomes in people with chronic kidney disease. Kidney Int. 2015 Oct;88(4):859-66. doi: 10.1038/ki.2015.228. Epub 2015 Jul 29.
PubMed 26221754Cockwell P, Fisher LA. The global burden of chronic kidney disease. Lancet. 2020 Feb 29;395(10225):662-664. doi: 10.1016/S0140-6736(19)32977-0. Epub 2020 Feb 13. No abstract available.
PubMed 32061314Docherty NG, le Roux CW. Bariatric surgery for the treatment of chronic kidney disease in obesity and type 2 diabetes mellitus. Nat Rev Nephrol. 2020 Dec;16(12):709-720. doi: 10.1038/s41581-020-0323-4. Epub 2020 Aug 10.
PubMed 32778788Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
PubMed 22449319Chagnac A, Weinstein T, Herman M, Hirsh J, Gafter U, Ori Y. The effects of weight loss on renal function in patients with severe obesity. J Am Soc Nephrol. 2003 Jun;14(6):1480-6. doi: 10.1097/01.asn.0000068462.38661.89.
PubMed 12761248Al-Bahri S, Fakhry TK, Gonzalvo JP, Murr MM. Bariatric Surgery as a Bridge to Renal Transplantation in Patients with End-Stage Renal Disease. Obes Surg. 2017 Nov;27(11):2951-2955. doi: 10.1007/s11695-017-2722-6.
PubMed 28500419Friedman AN, Wahed AS, Wang J, Courcoulas AP, Dakin G, Hinojosa MW, Kimmel PL, Mitchell JE, Pomp A, Pories WJ, Purnell JQ, le Roux C, Spaniolas K, Steffen KJ, Thirlby R, Wolfe B. Effect of Bariatric Surgery on CKD Risk. J Am Soc Nephrol. 2018 Apr;29(4):1289-1300. doi: 10.1681/ASN.2017060707. Epub 2018 Jan 15.
PubMed 29335242Friedman AN, Miskulin DC, Rosenberg IH, Levey AS. Demographics and trends in overweight and obesity in patients at time of kidney transplantation. Am J Kidney Dis. 2003 Feb;41(2):480-7. doi: 10.1053/ajkd.2003.50059.
PubMed 12552513Bolignano D, Zoccali C. Effects of weight loss on renal function in obese CKD patients: a systematic review. Nephrol Dial Transplant. 2013 Nov;28 Suppl 4:iv82-98. doi: 10.1093/ndt/gft302. Epub 2013 Oct 2.
PubMed 24092846
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery on Chronic Renal Disease (BARICADE): A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05240443
- Acronym / sponsor ID
- BARICADE / 2022-14388-GRA
- Conditions
- Bariatric Surgery, Chronic Kidney Diseases, Obesity
- Keywords
- Bariatric Surgery, Chronic Kidney Disease, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- American College of Surgeons, McMaster Surgical Associates
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 15 Feb 2022 (actual)
- 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.
Obesity can be a major driver for the development of chronic kidney disease (CKD), which is a leading cause of death and significant loss in quality of life. A growing body of evidence has shown bariatric (metabolic) surgery as a novel approach to reduce the progression of CKD and reduce morbidity with sustained weight loss. This pilot trial will inform the design and execution of a large RCT that could determine the efficacy of bariatric surgery in the treatment of patients with CKD in the context of obesity. Ultimately, the results have the potential to influence guidelines that may deem bariatric surgery as a viable treatment option for CKD and reduce the morbidity from this chronic condition and inform clinical practice.
Detailed description
Obesity is a major driver for the development of CKD, which is a leading cause of death and greatly reduces one's quality of life. With a global prevalence of 9.1% (7.2% in Canada), CKD affects an estimated 13.6% of the American population and was associated with over $50 billion in healthcare costs, with an additional $30 billion in costs associated with end-stage renal disease (ESRD). Moreover, with an aging Canadian population, the prevalence of CKD is expected to rise over the coming years with patients progressing to higher disease burdens. This, in part, has led to a substantial increase in renal replacement therapy by means of dialysis or kidney transplant by 43.1% since 1990. Obesity is also an important modulatory factor in the development of poor outcomes as a result of CKD and has been linked to an increased rate of progression from CKD towards kidney failure. The most common comorbidities in patients with CKD were hypertension, diabetes, heart failure, chronic pulmonary disease, and atrial fibrillation and in Canada, 25% of patients with CKD have at least 3 or more comorbidities which too are associated with an increased risk of hospitalization and early death. Most worryingly, unlike other non-communicable diseases today, the age-standardized mortality for CKD has not declined over the past decades. Therefore, innovative strategies are of timely importance to reduce mortality and morbidity in patients with CKD and thus urgently needed, especially in patients with multiple comorbidities and targeting weight loss is a promising avenue to find novel treatment options.
Bariatric surgery has been shown to not only facilitate sustained weight loss in patients with obesity, but also independently improve cardiac risk factors such as dyslipidemia, hypertension, and type 2 diabetes mellitus. It has also been shown to reverse glomerular hyperfiltration and lower proteinuria in patients with obesity and normal kidney function and delay the need for renal transplantation in patients with ESRD. Moreover, the protective benefit of bariatric surgery has been shown to reduce risk of CKD progression for up to seven years after intervention in observational studies. However, current guidelines do not address a role for bariatric surgery in the management of patients with obesity and CKD.
Given the poor outcomes with patients with obesity and CKD, a RCT to assess the efficacy and safety of bariatric surgery as an intervention for patients with CKD is of timely importance. The present proposed pilot RCT of bariatric surgery versus medical management alone for patients with morbid obesity and CKD in order to assess whether a large, multi-centre, efficacy trial is feasible. The results of the proposed pilot study will thus inform the design of a larger RCT in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-centre, open-label, parallel-arm feasibility randomized controlled trial with blinded endpoint assessment.
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery + Medical Management for Chronic Kidney Disease | Experimental | Procedure: Bariatric Surgery + Medical Management of CKD.The intervention group will include medical management and bariatric surgery, which will consist of Roux-en-Y gastric bypass or sleeve gastrectomy performed according to local practice standards. Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD. |
| Medical Management for Chronic Kidney Disease | Active comparator | Other: Medical Management for CKDMedical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient age >18
- Body mass index > 40 (or > 35 kg/m2 for patients with comorbidities)
- Diagnosis of CKD stage III (G3a or A2) defined as the presence of any of the following:
- Patient is deemed eligible to undergo bariatric surgery according to Ontario Bariatric Network (OBN) guidelines [contradictions to OBN guidelines include non-Ontario resident, age >70 years, history of cancer <2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites <1 year]
Key exclusion criteria (5 listed)
- Hospital admission for kidney failure or acute kidney injury within 30 days of enrollment
- Documented GFR > 60 mL/min/1.73 m2 or ACR < 30 mg/g within 30 days of enrollment
- Documented confounders of kidney function measurement such as urinary tract infection or use of creatinine elevating medications or use of medications which interfere with measurement
- Contradiction to OBN guidelines including non-Ontario resident, age >70 years, history of cancer <2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites <1 year
- Life expectancy <2 years due to non-CKD causes OR Untreated or inadequately treated psychiatric illness OR Risk of general anesthesia deemed too excessive OR Inability to provide informed consent
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 |
|---|---|---|
| Bariatric Surgery + Medical Management of CKD.The intervention group will include medical management and bariatric surgery, which will consist of Roux-en-Y gastric bypass or sleeve gastrectomy performed according to local practice standards. Medical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD. | Procedure or surgery | Bariatric Surgery + Medical Management for Chronic Kidney Disease |
| Medical Management for CKDMedical management for CKD will be directed by nephrologists at St. Joseph's Healthcare Hamilton. Comorbidities such as hypertension, dyslipidemia, and type 2 diabetes will be managed at the discretion of individual nephrologists. Generally, this can include anti-hypertensives (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) for systolic blood pressure control below a target of <140/90 mmHg (<130/80 in patients with type 2 diabetes), statins in patients with dyslipidemia to target low-density lipoprotein <2mmol/L for the treatment of CKD. | Other | Medical Management for Chronic Kidney Disease |
Primary outcome
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months
Time frame: Month 6
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 12 months
Time frame: Month 12
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 18 months
Time frame: Month 18
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months
Time frame: Month 6
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 12 months
Time frame: Month 12
Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 18 months
Time frame: Month 18
Creatine Clearance (units: mL/min) at 6 months
Time frame: Month 6
Creatine Clearance (units: mL/min) at 12 months
Time frame: Month 12
Creatine Clearance (units: mL/min) at 18 months
Time frame: Month 18
Serum Creatinine (units: μmol/L) at 6 months
Time frame: Month 6
Serum Creatinine (units: μmol/L) at 12 months
Time frame: Month 12
Serum Creatinine (units: μmol/L) at 18 months
Time frame: Month 18
Serum Cystatin C (units: mg/L) at 6 months
Time frame: Month 6
Serum Cystatin C (units: mg/L) at 12 months
Time frame: Month 12
Serum Cystatin C (units: mg/L) at 18 months
Time frame: Month 18
Urine Albumin-Creatine Ratio (units: mg/g) at 6 months
Time frame: Month 6
Urine Albumin-Creatine Ratio (units: mg/g) at 12 months
Time frame: Month 12
Urine Albumin-Creatine Ratio (units: mg/g) at 18 months
Time frame: Month 18
7 secondary outcomes
Weight and height will be combined to report BMI in kg/m^2 at 6 months
Time frame: Month 6
Weight and height will be combined to report BMI in kg/m^2 at 12 months
Time frame: Month 12
Weight and height will be combined to report BMI in kg/m^2 at 18 months
Time frame: Month 18
Recruitment Rate (60 patients will be recruited at an average recruitment rate of 1.25 patients per site per month.)
Time frame: Month 6
Intervention Administration Rate
Time frame: Month 6
Crossover rate between control and intervention arm
Time frame: Month 6
Number of patients adhering to study treatments
Time frame: Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Background: PubMed 28236831Saran R, Robinson B, Abbott KC, Agodoa LY, Albertus P, Ayanian J, Balkrishnan R, Bragg-Gresham J, Cao J, Chen JL, Cope E, Dharmarajan S, Dietrich X, Eckard A, Eggers PW, Gaber C, Gillen D, Gipson D, Gu H, Hailpern SM, Hall YN, Han Y, He K, Hebert H, Helmuth M, Herman W, Heung M, Hutton D, Jacobsen SJ, Ji N, Jin Y, Kalantar-Zadeh K, Kapke A, Katz R, Kovesdy CP, Kurtz V, Lavalee D, Li Y, Lu Y, McCullough K, Molnar MZ, Montez-Rath M, Morgenstern H, Mu Q, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Pearson J, Pisoni R, Plattner B, Port FK, Potukuchi P, Rao P, Ratkowiak K, Ravel V, Ray D, Rhee CM, Schaubel DE, Selewski DT, Shaw S, Shi J, Shieu M, Sim JJ, Song P, Soohoo M, Steffick D, Streja E, Tamura MK, Tentori F, Tilea A, Tong L, Turf M, Wang D, Wang M, Woodside K, Wyncott A, Xin X, Zang W, Zepel L, Zhang S, Zho H, Hirth RA, Shahinian V. US Renal Data System 2016 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2017 Mar;69(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2016.12.004. No abstract available.
- Background: PubMed 17986697Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
- Background: PubMed 30993231Bello AK, Ronksley PE, Tangri N, Kurzawa J, Osman MA, Singer A, Grill A, Nitsch D, Queenan JA, Wick J, Lindeman C, Soos B, Tuot DS, Shojai S, Brimble S, Mangin D, Drummond N. Prevalence and Demographics of CKD in Canadian Primary Care Practices: A Cross-sectional Study. Kidney Int Rep. 2019 Jan 21;4(4):561-570. doi: 10.1016/j.ekir.2019.01.005. eCollection 2019 Apr.
- Background: PubMed 32061315GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
- Background: PubMed 21623393Eknoyan G. Obesity and chronic kidney disease. Nefrologia. 2011;31(4):397-403. doi: 10.3265/Nefrologia.pre2011.May.10963. Epub 2011 May 30.
- Background: PubMed 26221754Tonelli M, Wiebe N, Guthrie B, James MT, Quan H, Fortin M, Klarenbach SW, Sargious P, Straus S, Lewanczuk R, Ronksley PE, Manns BJ, Hemmelgarn BR. Comorbidity as a driver of adverse outcomes in people with chronic kidney disease. Kidney Int. 2015 Oct;88(4):859-66. doi: 10.1038/ki.2015.228. Epub 2015 Jul 29.
- Background: PubMed 32061314Cockwell P, Fisher LA. The global burden of chronic kidney disease. Lancet. 2020 Feb 29;395(10225):662-664. doi: 10.1016/S0140-6736(19)32977-0. Epub 2020 Feb 13. No abstract available.
- Background: PubMed 32778788Docherty NG, le Roux CW. Bariatric surgery for the treatment of chronic kidney disease in obesity and type 2 diabetes mellitus. Nat Rev Nephrol. 2020 Dec;16(12):709-720. doi: 10.1038/s41581-020-0323-4. Epub 2020 Aug 10.
- Background: PubMed 22449319Schauer PR, Kashyap SR, Wolski K, Brethauer SA, Kirwan JP, Pothier CE, Thomas S, Abood B, Nissen SE, Bhatt DL. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012 Apr 26;366(17):1567-76. doi: 10.1056/NEJMoa1200225. Epub 2012 Mar 26.
- Background: PubMed 12761248Chagnac A, Weinstein T, Herman M, Hirsh J, Gafter U, Ori Y. The effects of weight loss on renal function in patients with severe obesity. J Am Soc Nephrol. 2003 Jun;14(6):1480-6. doi: 10.1097/01.asn.0000068462.38661.89.
- Background: PubMed 28500419Al-Bahri S, Fakhry TK, Gonzalvo JP, Murr MM. Bariatric Surgery as a Bridge to Renal Transplantation in Patients with End-Stage Renal Disease. Obes Surg. 2017 Nov;27(11):2951-2955. doi: 10.1007/s11695-017-2722-6.
- Background: PubMed 29335242Friedman AN, Wahed AS, Wang J, Courcoulas AP, Dakin G, Hinojosa MW, Kimmel PL, Mitchell JE, Pomp A, Pories WJ, Purnell JQ, le Roux C, Spaniolas K, Steffen KJ, Thirlby R, Wolfe B. Effect of Bariatric Surgery on CKD Risk. J Am Soc Nephrol. 2018 Apr;29(4):1289-1300. doi: 10.1681/ASN.2017060707. Epub 2018 Jan 15.
- Individual participant dataSharing planned: No
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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.
Dennis Hong, MD MSc FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Surgery + Medical Management of CKD. and Medical Management for CKD in people with Bariatric Surgery and Chronic Kidney Diseases, run by McMaster University at 1 site in Canada.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yung Lee, MD (416 732 7306, yung.lee@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months (time frame: Month 6). The study lists 18 primary outcomes in all. 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 NCT05240443, which also lists 14 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 15 Feb 2022.