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NCT05005793 · ClinicalTrials.gov registry record · Phase 4
Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
A Phase 4 study of Vascular Diseases and Kidney Transplant; Complications, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05005793: Recruiting Phase 4 study of Vascular Diseases and Kidney Transplant; Complications, sponsored by University of Colorado, Denver.
NCT05005793 is a Phase 4 study of Vascular Diseases and Kidney Transplant; Complications that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 120 participants, below the 558-participant average among 40 other Vascular Diseases trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05005793, a Phase 4 study of Vascular Diseases and Kidney Transplant; Complications, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also result in improved vascular and graft function. The investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 KTRs to examine the effect of sodium bicarbonate therapy on surrogate markers of CVD and graft function. The overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in KTRs by decreasing complement activation.
Primary Outcome
Brachial artery FMD will be determined using high-resolution ultrasonographyECG-gated end-diastolic ultrasound images and Doppler flow of the brachial artery will be acquired during baseline and FMD conditions. For FMD, reactive hyperemia will be produced by inflating a pediatric BP cuff around the forearm to 250 mmHg for 5 minutes followed by rapid deflation.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sodium bicarbonate
Study Locations (1)
Colorado
- University of Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 4 |
What NCT05005793 shows while recruiting
NCT05005793 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 558-participant average among 40 other Vascular Diseases trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Vascular Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05005793 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05005793 about?
NCT05005793 is a clinical study titled "Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients". Lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also res...
What is the current status of trial NCT05005793?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2021-12-01. Estimated completion is 2026-08-31.
What conditions does trial NCT05005793 study?
This clinical trial studies the following conditions: Vascular Diseases, Kidney Transplant; Complications, Metabolic Acidosis.
What interventions are being tested in trial NCT05005793?
The interventions under investigation include: Placebo (DRUG), Sodium bicarbonate (DRUG).
Who is sponsoring clinical trial NCT05005793?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05005793 being conducted?
This trial has 1 study location across Colorado. 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 NCT05005793's enrollment target sits among peer trials
120 25th of 40 higher than 16 of 40 other Vascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vascular 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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