Renal Impairment Clinical Trial
Official title:
A Single Dose Evaluation of the Effects of Renal Impairment on Deflazacort Pharmacokinetics
This is a non-randomized, open-label, single-dose study to compare the PK of 21 desacetyl-DFZ and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy matched control subjects (age, body mass index [BMI], and gender).
This is a non-randomized, open-label, single-dose study to compare the PK of 21 desacetyl-DFZ
and, if data permits, deflazacort in 8 subjects with ESRD to that of 8 healthy matched
control subjects (age, body mass index [BMI], and gender).
All subjects with ESRD will be on hemodialysis (HD). Dosing of deflazacort followed by PK
evaluation of 21 desacetyl DFZ and, if data permits, deflazacort, will only be performed on a
non-HD day.
On Day 1, that will be scheduled on a non-HD day for subjects with ESRD, a single oral dose
of deflazacort will be administered followed by serial blood sampling for 24 hours to assess
the PK of 21 desacetyl-DFZ, and, if data permits, deflazacort.
Safety will be monitored throughout the study by repeated clinical and laboratory
evaluations.
Subjects will return to the Clinical Research Unit (CRU) 3 days (± 1 day) following study
drug administration to determine if any adverse events (AEs) have occurred since the last
study visit. Subjects who terminate the study early will be contacted if the Principal
Investigator (PI) deems necessary.
A total of sixteen (16) adult male and female subjects will be enrolled. Renal Impaired
Cohort: Eight (8) subjects with ESRD on HD. Healthy Match Control Cohort: Eight (8) healthy
subjects with estimated creatinine clearance (CLcr) ≥ 90 mL/min. Subjects will be matched for
age [± 15 years], BMI [± 15 %], and gender [1:1] to the subjects in the ESRD cohort.
Each subject will receive a single oral dose of 18 mg (3 X 6 mg tablets) deflazacort,
following an overnight fast.
Study drug will be administered orally with approximately 240 mL of water.
;
| 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 |
NCT00842868 -
The CASABLANCA Study: Catheter Sampled Blood Archive in Cardiovascular Diseases
|
N/A | |
| Completed |
NCT00750620 -
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
|
Phase 1 | |
| 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 |