Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04600323 · ClinicalTrials.gov registry record · Early Phase 1
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
A Early Phase 1 study of Chronic Kidney Disease and Cognitive Dysfunction, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT04600323: Completed Early Phase 1 study of Chronic Kidney Disease and Cognitive Dysfunction, sponsored by University of Colorado, Denver.
NCT04600323 is a Early Phase 1 study of Chronic Kidney Disease and Cognitive Dysfunction that has completed, run by University of Colorado, Denver. The registered enrollment target is 34 participants, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04600323, a Early Phase 1 study of Chronic Kidney Disease and Cognitive Dysfunction, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with CKD stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.
Primary Outcome
Cognitive function will be determined using the NIH Toolbox-Cognition Battery computerized tests. The Cognitive function composite score is based on the average of the Fluid and Crystallized composites. It is derived by averaging the Fluid and Crystallized standard scores, then deriving standard scores based on this new distribution. Fully Corrected T-scores are adjusted for for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in t
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sodium Bicarbonate Tablets
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2023-08-30 |
| Phase | Early Phase 1 |
What the finished NCT04600323 record still lists
NCT04600323 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 3,206-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04600323 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04600323 about?
NCT04600323 is a clinical study titled "Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD". This is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with CKD stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.
What is the current status of trial NCT04600323?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 34 participants. The study started on 2021-02-01. Estimated completion is 2023-08-30.
What conditions does trial NCT04600323 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Cognitive Dysfunction, Metabolic Acidosis.
What interventions are being tested in trial NCT04600323?
The interventions under investigation include: Placebo (DRUG), Sodium Bicarbonate Tablets (DRUG).
Who is sponsoring clinical trial NCT04600323?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04600323 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
Similar trials for Chronic Kidney Disease
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 NCT04600323's enrollment target sits among peer trials
34 80th of 101 higher than 21 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease 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
-
Effects of Vitamin D Replacement on Hormones Regulating Iron Metabolism in Individuals With Chronic Kidney Disease
COMPLETED · Early Phase 1
-
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
RECRUITING · Phase 2
-
Patient-driven Management of BP in CKD
RECRUITING · Phase 3
-
A Natural History Study of Metabolic Sizing in Health and Disease
RECRUITING
-
Pivotal Study of the Velocity™ pAVF System
RECRUITING · NA
-
Safety of Short-course of NSAIDs in Pediatric Patients With CKD
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI