Measurement of Renal Functional Reserve

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Mass General Brigham

Status

Completed

Conditions

Kidney Diseases

Treatments

Dietary Supplement: Ingestion of protein

Study type

Interventional

Funder types

Other

Identifiers

NCT03190070
2016P002287

Details and patient eligibility

About

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

Full 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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

47 participants in 1 patient group

Study group
Experimental group
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).
Treatment:
Dietary Supplement: Ingestion of protein

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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