NCT05158959

Brief Summary

This study investigates renal functional reserve in elderly.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 24, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

December 15, 2021

Status Verified

September 1, 2021

Enrollment Period

2.7 years

First QC Date

December 2, 2021

Last Update Submit

December 2, 2021

Conditions

Keywords

Renal functional reserve, CKD progression, Elderly

Outcome Measures

Primary Outcomes (1)

  • Change of renal functional reserve per 12 months (mL/min)

    Renal functional reserve defined as the difference between baseline creatinine clearance and creatinine clearance achieved under stimulation with amino acid infusion.

    12 months

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elders age more than 60 years who are non-frail and has no limited life expectancy

You may qualify if:

  • Patient age \> 60 years at screening
  • Patient willing to participate in the study and can provide inform consent
  • Patient have residual kidney function ≤ 90 ml/min/1.73m2 by CKD-EPI equation

You may not qualify if:

  • Patient active smoking
  • Patient have Charlson comorbidity index \> .....
  • Patient active cancer
  • Patient contraindications for blood collection
  • Patients with a history of hypersensitivity to cimetidine or amino acid IV solution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kearkiat Praditpornsilpa

Bangkok, 10330, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 15, 2021

Study Start

October 24, 2019

Primary Completion

June 30, 2022

Study Completion

December 30, 2022

Last Updated

December 15, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations