Renal Impairment Clinical Trial
Official title:
Effects of Cardiopulmonary Bypass on Urinary Secretion of NAG
NAG is a protein excreted in urine in cases of tubular damage, and is considered a biomarker of kidney injury. Elevated urinary NAG is seen after cardiac surgery, but the clinical significance, pattern of excretion and links to perioperative factors are poorly described. We plan a study of the pattern of NAG-excretion during cardiac surgery with cardiopulmonary bypass, and explore possible associated variables.
The standard biomarker of AKI, serum creatinine, has poor specificity and sensitivity in the
early phases of renal injury. Since the therapeutic window is likely to be in the earlier
stages before renal injury is manifest, there is a need for novel diagnostic methods. In the
recent years, several new biomarkers of kidney injury have been introduced. To date, none
has proven outstanding regarding precision in early detection of AKI. NAG
(N-acetyl-b-D-glucosaminidase) is a lysosomal enzyme with high molecular weight. Due to its
size, NAG does not normally pass the glomerulus apparatus, but urine levels are elevated
after tubulus damage. NAG excretion in urine is seen in AKI after cardiac surgery, exposure
to nephrotoxic agents and after renal transplantation. However, its role in clinical
decision-making is yet to be established.
We aim to study the excretion pattern of urinary NAG during and after cardiac surgery with
cardiopulmonary bypass. Association with perioperative variables will be explored.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01937975 -
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
|
Phase 1 | |
| Completed |
NCT03284164 -
Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
|
Phase 1 | |
| Completed |
NCT05992155 -
A Study of TAK-279 in Adults With or Without Kidney Problems
|
Phase 1 | |
| Completed |
NCT05004311 -
The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics
|
Phase 1 | |
| Completed |
NCT04963738 -
A Study of JNJ-73763989 in Adult Participants With Renal Impairment
|
Phase 1 | |
| Terminated |
NCT02508740 -
Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment
|
Phase 1 | |
| Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
| Terminated |
NCT00984113 -
Pharmacokinetics of Elinogrel in Healthy Volunteers and Patients With Mild, Moderate, and Severe Renal Impairment
|
Phase 1 | |
| Completed |
NCT00750620 -
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
|
Phase 1 | |
| Completed |
NCT00842868 -
The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases
|
N/A | |
| Completed |
NCT00499187 -
Fanconi Syndrome Due to ARVs in HIV-Infected Persons
|
Phase 4 | |
| Completed |
NCT01331941 -
A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
|
Phase 1 | |
| Completed |
NCT05489614 -
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participants With Various Degrees of Renal Impairment
|
Phase 1 | |
| Completed |
NCT03259087 -
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
|
Phase 1 | |
| Completed |
NCT05086107 -
Pharmacokinetics and Safety of BV100 Administered as Single Intravenous Infusion to Subjects With Renal Impairment
|
Phase 1 | |
| Recruiting |
NCT05349851 -
Bowel Cleansing With Renal Impairment
|
||
| Completed |
NCT03660241 -
A Renal Impairment Study for PF-04965842
|
Phase 1 | |
| Recruiting |
NCT06037031 -
A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function
|
Phase 1 | |
| Completed |
NCT03289208 -
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
|
Phase 1 | |
| Completed |
NCT02942810 -
To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
|
Phase 1 |