Back to resultsMeasurement of Renal Functional Reserve
Primary Purpose
Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ingestion of protein
Sponsored by
About this trial
This is an interventional other trial for Kidney Diseases focused on measuring Renal reserve, physiological study, diagnostic testing
Eligibility Criteria
Inclusion Criteria:
- Age ≥18
- Estimated GFR >30 mL/min/1.73m2
Exclusion Criteria:
- Allergy to iothalamate, shellfish or iodine
- Use of metformin or amiodarone
- Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
- Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
- Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
- Inadequate intravenous access
- Severe anemia (Hct <21%)
- Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
- History of contrast-induced nephropathy
- Hyperthyroidism
- Pheochromocytoma
- Sickle cell disease
- Urinary retention or incontinence
- Status post organ transplant
- Pregnancy or active breast feeding
- Cognitive impairment with inability to give consent
- Institutionalized status
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study group
Arm Description
All study participants are in the same group and will have their kidney function measured twice, before and after ingestion of protein, 1 g/(kg body weight). The protein will be given in the form of the protein drink Liquacel (Global Health Products, Rochester, NY).
Outcomes
Primary Outcome Measures
Change in glomerular filtration rate after ingestion of protein
Short term-changes in the glomerular filtration rate will be measured before and after ingestion of oral protein
Secondary Outcome Measures
Full Information
NCT ID
NCT03190070
First Posted
June 14, 2017
Last Updated
August 8, 2022
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03190070
Brief Title
Measurement of Renal Functional Reserve
Official Title
Measurement of Renal Functional Reserve With Urinary Clearance of Cold Iothalamate Before and After an Oral Protein Load
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single arm physiological study to measure renal functional reserve as a biomarker of kidney function and health
Detailed Description
The investigators will measure glomerular filtration rate using urinary clearance of cold iothalamate before and after an oral protein load in patients with chronic kidney disease and healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases
Keywords
Renal reserve, physiological study, diagnostic testing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Physiological study to measure the change in glomerular filtration rate after an oral protein load
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
All study participants are in the same group and will have their kidney function measured twice, before and after ingestion of protein, 1 g/(kg body weight). The protein will be given in the form of the protein drink Liquacel (Global Health Products, Rochester, NY).
Intervention Type
Dietary Supplement
Intervention Name(s)
Ingestion of protein
Other Intervention Name(s)
Liquacel (Global Health Products, Rochester, NY)
Intervention Description
Oral protein load as a physiological stimulus to temporarily increase glomerular filtration rate
Primary Outcome Measure Information:
Title
Change in glomerular filtration rate after ingestion of protein
Description
Short term-changes in the glomerular filtration rate will be measured before and after ingestion of oral protein
Time Frame
Single full-day clinic visit: Repeated glomerular filtration rate measurements are to be performed over the course of the day at a single study visit for each participant.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥18
Estimated GFR >30 mL/min/1.73m2
Exclusion Criteria:
Allergy to iothalamate, shellfish or iodine
Use of metformin or amiodarone
Inability to maintain a stable regimen of medications which affect GFR for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
Inadequate intravenous access
Severe anemia (Hct <21%)
Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
History of contrast-induced nephropathy
Hyperthyroidism
Pheochromocytoma
Sickle cell disease
Urinary retention or incontinence
Status post organ transplant
Pregnancy or active breast feeding
Cognitive impairment with inability to give consent
Institutionalized status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sushrut Waikar, MD MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29793670
Citation
Palsson R, Waikar SS. Renal Functional Reserve Revisited. Adv Chronic Kidney Dis. 2018 May;25(3):e1-e8. doi: 10.1053/j.ackd.2018.03.001.
Results Reference
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Measurement of Renal Functional Reserve
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