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NCT05880914 · ClinicalTrials.gov registry record
Precision Medicine Approaches to Renal Osteodystrophy
A clinical trial of Chronic Kidney Diseases and Secondary Hyperparathyroidism, sponsored by Thomas Nickolas.
- Recruiting
- Registry status
- 40
- Enrollment target
- 1
- Study location
NCT05880914: Recruiting study of Chronic Kidney Diseases and Secondary Hyperparathyroidism, sponsored by Thomas Nickolas.
NCT05880914 is a study of Chronic Kidney Diseases and Secondary Hyperparathyroidism that is actively recruiting participants, run by Thomas Nickolas. The registered enrollment target is 40 participants, below the 444-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05880914, a study of Chronic Kidney Diseases and Secondary Hyperparathyroidism, is actively recruiting participants, sponsored by Thomas Nickolas.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Treatment of renal osteodystrophy is impeded by the lack of practical and accurate tools to determine underlying bone turnover. Gold standard bone biopsy is not practical in the clinic for the vast majority of kidney disease patients and parathyroid hormone and bone alkaline phosphatase have insufficient accuracy for turnover type to safely and confidently guide treatment of renal osteodystrophy. In the present investigation, the investigators will study a microRNA approach as a novel non-invasive biomarker of turnover for renal osteodystrophy.
Primary Outcome
To determine the utility of a miRNA panel to discriminate changes in bone turnover. miRNA sequencing libraries will be prepared using the QIASeq miRNA Library Kit (Qiagen). Total RNA extracted from human serum will be used as the starting material. After a final library cleanup, the miRNA libraries will be QC and quantified using an Agilent Bioanalyzer 2100 and Invitrogen Qubit Fluorometer. The resulting miRNA libraries will be sequenced on an Illumina NextSeq 500 (Illumina, San Diego, CA) with
Conditions Studied
Interventions
- PROCEDURE miRNAseq analysis
- DRUG Standard treatment for bone disorder
Study Locations (1)
Missouri
- Washington University in St. Louis (WashU) - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-12-21 |
| Est. Completion | 2027-06-30 |
What NCT05880914 shows while recruiting
NCT05880914 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 444-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 2 interventions - of which miRNAseq analysis is the first listed.
NCT05880914 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05880914 about?
NCT05880914 is a clinical study titled "Precision Medicine Approaches to Renal Osteodystrophy". Treatment of renal osteodystrophy is impeded by the lack of practical and accurate tools to determine underlying bone turnover. Gold standard bone biopsy is not practical in the clinic for the vast majority of kidney disease patients and parathyroid hormone and bone alkaline phosphatase have insuffi...
What is the current status of trial NCT05880914?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2022-12-21. Estimated completion is 2027-06-30.
What conditions does trial NCT05880914 study?
This clinical trial studies the following conditions: Chronic Kidney Diseases, Secondary Hyperparathyroidism, Renal Osteodystrophy, CKD-MBD, Bone Turnover Rate Disorder.
What interventions are being tested in trial NCT05880914?
The interventions under investigation include: miRNAseq analysis (PROCEDURE), Standard treatment for bone disorder (DRUG).
Who is sponsoring clinical trial NCT05880914?
This trial is sponsored by Thomas Nickolas, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05880914 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05880914's enrollment target sits among peer trials
40 56th of 73 higher than 16 of 73 other Chronic Kidney Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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