Measurement of Renal Functional Reserve

Not Applicable

Completed

• Conditions: Kidney Diseases
• Interventions: Dietary Supplement: Ingestion of protein

• Registration Number: NCT03190070
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-16
• Study Start: 2017-07-12
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Ingestion of protein	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).

Primary Outcome Measures

Name	Time	Method
Change in glomerular filtration rate after ingestion of 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.	Short term-changes in the glomerular filtration rate will be measured before and after ingestion of oral protein

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States