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OpenTrials
Completed

NCT Number: NCT03190070

Measurement of Renal Functional Reserve

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ingestion of protein

Dietary Supplement

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

Other names: Liquacel (Global Health Products, Rochester, NY)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Measurement of Renal Functional Reserve With Urinary Clearance of Cold Iothalamate Before and After an Oral Protein Load

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2017
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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