Measurement of Renal Functional Reserve

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-12

Study Completion Date

2021-12-01

Brief Summary

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

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Detailed Description

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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

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Kidney Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study group

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).

Group Type EXPERIMENTAL

Ingestion of protein

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Ingestion of protein

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Liquacel (Global Health Products, Rochester, NY)

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18
2. Estimated GFR \>30 mL/min/1.73m2

Exclusion Criteria

1. Allergy to iothalamate, shellfish or iodine
2. Use of metformin or amiodarone
3. 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)
4. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
5. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy
6. Inadequate intravenous access
7. Severe anemia (Hct \<21%)
8. 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)
9. History of contrast-induced nephropathy
10. Hyperthyroidism
11. Pheochromocytoma
12. Sickle cell disease
13. Urinary retention or incontinence
14. Status post organ transplant
15. Pregnancy or active breast feeding
16. Cognitive impairment with inability to give consent
17. Institutionalized status

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes