Kidney DiseasesNCT03190070
Measurement of Renal Functional Reserve
A study testing Ingestion of protein in people with Kidney Diseases, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Single arm physiological study to measure renal functional reserve as a biomarker of kidney function and health Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Ingestion of protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2017to 1 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18
- Estimated GFR >30 mL/min/1.73m2
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Measurement of Renal Functional Reserve With Urinary Clearance of Cold Iothalamate Before and After an Oral Protein Load
Single arm physiological study to measure renal functional reserve as a biomarker of kidney function and health
Read the 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.
- Conditions
- Kidney Diseases
- Being tested
- Ingestion of protein
- Keywords
- Renal reserve, physiological study, diagnostic testing
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingestion of proteinDietary supplement
Also called Liquacel (Global Health Products, Rochester, NY)
Oral protein load as a physiological stimulus to temporarily increase glomerular filtration rate
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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). Receives: Dietary Supplement: Ingestion of protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start12 Jul 2017
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Physiological study to measure the change in glomerular filtration rate after an oral protein load
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sushrut S Waikar, Brigham and Women's Hospital
- Investigators
- Sushrut Waikar, MD MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190070
- Sponsor's protocol ID
- 2016P002287
- Status last verified
- Aug 2022
- First submitted
- 14 Jun 2017
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29793670
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Renal Functional Reserve With Urinary Clearance of Cold Iothalamate Before and After an Oral Protein Load
- ClinicalTrials.gov ID
- NCT03190070
- Acronym / sponsor ID
- 2016P002287
- Conditions
- Kidney Diseases
- Keywords
- Renal reserve, physiological study, diagnostic testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 16 Jun 2017 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Physiological study to measure the change in glomerular filtration rate after an oral protein load
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Dietary Supplement: Ingestion of proteinAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18
- Estimated GFR >30 mL/min/1.73m2
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Ingestion of proteinAlso: Liquacel (Global Health Products, Rochester, NY)Oral protein load as a physiological stimulus to temporarily increase glomerular filtration rate | Dietary supplement | Study group |
Primary outcome
Change in glomerular filtration rate after ingestion of 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.
Short term-changes in the glomerular filtration rate will be measured before and after ingestion of oral protein
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Background: PubMed 29793670Palsson 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.
- 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.
Sushrut Waikar, MD MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ingestion of protein in people with Kidney Diseases, run by Brigham and Women's Hospital 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 17 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: finished, as of the sponsor's last update on 10 Aug 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in glomerular filtration rate after ingestion of 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.). 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 NCT03190070, which also lists 1 linked publication.
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 10 Aug 2022; AzTrials last refreshed its copy on 2 Nov 2026.