Measurement of Renal Functional Reserve

NCT03190070 | Completed

• 1 other identifier: 2016P002287
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Single arm physiological study to measure renal functional reserve as a biomarker of kidney function and health

Conditions

Kidney Diseases

Keywords

Renal reserve, physiological study, diagnostic testing

Outcome Measures

Primary Outcomes (1)

• 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

  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.

Study Arms (1)

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).

Dietary Supplement: Ingestion of protein

Interventions

Ingestion of protein DIETARY_SUPPLEMENT

Oral protein load as a physiological stimulus to temporarily increase glomerular filtration rate

Also known as: Liquacel (Global Health Products, Rochester, NY)

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Estimated GFR \>30 mL/min/1.73m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 29793670 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sushrut Waikar, MD MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Constantine L. Hampers, MD Distinguished Chair in Renal Medicine

Model Details: Physiological study to measure the change in glomerular filtration rate after an oral protein load

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: July 12, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)