Bariatric Surgery and Chronic Renal Disease

NCT05240443 | Unknown DMC

• 1 other identifier: 2022-14388-GRA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Bariatric Surgery; Chronic Kidney Diseases; Obesity

Keywords

Bariatric Surgery; Chronic Kidney Disease; Obesity

Outcome Measures

Primary Outcomes (18)

• Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months

  Month 6

• Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 12 months

  Month 12

• Estimated Glomerular Filtration Rate (units: ml/min/1.73m2) at 18 months

  Month 18

• Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 6 months

  Month 6

• Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 12 months

  Month 12

• Measured Glomerular Filtration Rate (units: ml/min/1.73m2) at 18 months

  Month 18

• Creatine Clearance (units: mL/min) at 6 months

  Month 6

• Creatine Clearance (units: mL/min) at 12 months

  Month 12

• Creatine Clearance (units: mL/min) at 18 months

  Month 18

• Serum Creatinine (units: μmol/L) at 6 months

  Month 6

• Serum Creatinine (units: μmol/L) at 12 months

  Month 12

• Serum Creatinine (units: μmol/L) at 18 months

  Month 18

• Serum Cystatin C (units: mg/L) at 6 months

  Month 6

• Serum Cystatin C (units: mg/L) at 12 months

  Month 12

• Serum Cystatin C (units: mg/L) at 18 months

  Month 18

• Urine Albumin-Creatine Ratio (units: mg/g) at 6 months

  Month 6

• Urine Albumin-Creatine Ratio (units: mg/g) at 12 months

  Month 12

• Urine Albumin-Creatine Ratio (units: mg/g) at 18 months

  Month 18

Secondary Outcomes (7)

• Weight and height will be combined to report BMI in kg/m^2 at 6 months

  Month 6

• Weight and height will be combined to report BMI in kg/m^2 at 12 months

  Month 12

• Weight and height will be combined to report BMI in kg/m^2 at 18 months

  Month 18

• Recruitment Rate (60 patients will be recruited at an average recruitment rate of 1.25 patients per site per month.)

  Month 6

• Intervention Administration Rate

  Month 6

Study Arms (2)

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.

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.

Other: Medical Management for CKD

Interventions

Bariatric Surgery + Medical Management of CKD. PROCEDURE

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.

Bariatric Surgery + Medical Management for Chronic Kidney Disease

Medical Management for CKD OTHER

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[contradictions to OBN guidelines include non-Ontario resident, age \>70 years, history of cancer \<2 years, current substance use disorder, accessed palliative care, previous organ transplant (liver, heart, or lungs), active cardiac disease, major revascularization procedures within 6 months, or severe liver disease with ascites \<1 year\]

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• American College of Surgeons: collaborator
• McMaster Surgical Associates: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (14)

• 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.

  PMID: 28236831 BACKGROUND

• Coresh 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.

  PMID: 17986697 BACKGROUND

• Bello 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.

  PMID: 30993231 BACKGROUND

• GBD 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.

  PMID: 32061315 BACKGROUND

• Eknoyan G. Obesity and chronic kidney disease. Nefrologia. 2011;31(4):397-403. doi: 10.3265/Nefrologia.pre2011.May.10963. Epub 2011 May 30.

  PMID: 21623393 BACKGROUND

• Tonelli 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.

  PMID: 26221754 BACKGROUND

• Cockwell 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.

  PMID: 32061314 BACKGROUND

• Docherty 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.

  PMID: 32778788 BACKGROUND

• Schauer 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.

  PMID: 22449319 BACKGROUND

• Chagnac 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.

  PMID: 12761248 BACKGROUND

• Al-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.

  PMID: 28500419 BACKGROUND

• Friedman 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.

  PMID: 29335242 BACKGROUND

• Friedman 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.

  PMID: 12552513 BACKGROUND

• Bolignano 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.

  PMID: 24092846 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Dennis Hong, MD MSc FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung Lee, MD

CONTACT

416 732 7306; yung.lee@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-centre, open-label, parallel-arm feasibility randomized controlled trial with blinded endpoint assessment.

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 15, 2022
• Study Start: April 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)