NCT00001978

Brief Summary

Much more about kidney disorders can be learned by determining kidney function. This research proposes to study the kidneys function by several parameters known as glomerular filtration rate (GFR), Renal Plasma Flow (RPF), and Glomerular Capillary Wall Permselectivity. The study will select patients suffering from different types of kidney diseases. These patients will be selected based on the presence of significant amounts of protein in their urine (proteinuria). Standard blood and urine tests are often unable to provide completely accurate information about the kidney. In order for researchers to have a more accurate idea of kidney function, they will use alternative tests. Test materials (para aminohippurate and inulin) will be injected into patients veins that provides information based on their filtration through the kidneys....

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1989

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 1989

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2000

Completed
20.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

31 years

First QC Date

January 20, 2000

Last Update Submit

October 5, 2020

Conditions

Kidney DiseaseProteinuriaAutoimmune / Connective Tissue Diseases

Keywords

Kidney DiseaseKidney Function TestsProteinuria

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate

    Glomerular filtration rate, effective renal plasma flow and /or glomerular permselectivity can be measured simultaneously during astandard hydrated urinary clearance study. Timed urine and blood collections will be obtained, typically requiring a total of 60 to 90 minutes. The total test time, including pretest hydration, is 4 to 5 hours.

    4-5 hours

Secondary Outcomes (1)

  • Effective renal plasma flow

Study Arms (1)

Study Cohort

Selected patients with proteinuria

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary clinical and community sample

You may qualify if:

  • Ability to provide informed assent to all aspects of the study after full information is provided.
  • An indication to measure kidney function as accurately as possible in the context of an approved clinical protocol within the intramural programs of the National Institutes of Health:
  • For minor subjects, a clinical indication will be required.
  • For adult subjects, a clinical and/or research indication will be required.

You may not qualify if:

  • Pregnant females or nursing mothers will be excluded from all aspects of this study (at least until the infant is stable on a regimen of formula feeding).
  • Patients will not receive a test material if there is a history of allergy to that material.
  • Patients with a history of bronchial asthma or allergy to iodine-containing contrast material will not receive iothalamate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Shemesh O, Golbetz H, Kriss JP, Myers BD. Limitations of creatinine as a filtration marker in glomerulopathic patients. Kidney Int. 1985 Nov;28(5):830-8. doi: 10.1038/ki.1985.205.

    PMID: 2418254BACKGROUND

  • Bauer JH, Brooks CS, Burch RN. Clinical appraisal of creatinine clearance as a measurement of glomerular filtration rate. Am J Kidney Dis. 1982 Nov;2(3):337-46. doi: 10.1016/s0272-6386(82)80091-7.

    PMID: 7148824BACKGROUND

  • Blythe WB. The endogenous creatinine clearance. Am J Kidney Dis. 1982 Nov;2(3):321-3. doi: 10.1016/s0272-6386(82)80089-9. No abstract available.

    PMID: 7148823BACKGROUND

Related Links

MeSH Terms

Conditions

Kidney DiseasesProteinuriaConnective Tissue Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin and Connective Tissue Diseases

Study Officials

  • Meryl A Waldman, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2000

First Posted

January 21, 2000

Study Start

October 11, 1989

Primary Completion

October 2, 2020

Study Completion

October 2, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

US(1)