Measurement of Renal Functional Reserve

Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190070
• Other study ID #: 2016P002287
• Status: Completed
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases

Intervention

Dietary Supplement:
• Ingestion of protein
Oral protein load as a physiological stimulus to temporarily increase glomerular filtration rate

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.