Renal Insufficiency Clinical Trial
Official title:
Prospective, Randomized Trial on the Clinical Utility of Drug-coated Balloons After Angioplasty of Plain Old Balloon-resistent Dialysis Fistula Stenosis Using Cutting Ballons
The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1
year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts
62-87%), necessitating a therapeutic measure to preserve dialysis access during this period
in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a
standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success
rate of 50-79% [2-4].In turn, in 21-50% of the cases an insufficient PTA result is obtained
(so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting
balloon (carrying with small knives on its surface) is performed, leading to a success rate
of 89%. However, a problem is the high incidence of restenosis, which is about 40% for
recurrent stenosis and over 10% in de novo stenosis.
The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in
the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is
unknown.
Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of
a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses
compared to the sole use of a cutting balloon.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05990660 -
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery
|
N/A | |
| Recruiting |
NCT04096547 -
Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
|
||
| Completed |
NCT04024332 -
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
|
Phase 1 | |
| Completed |
NCT02849964 -
Factors Related to Geographical Variation in the Incidence of End-stage Renal Failure: An Analysis in 5 French Regions
|
N/A | |
| Active, not recruiting |
NCT03672110 -
Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen
|
Phase 3 | |
| Completed |
NCT01462136 -
PK Study of ACHN-490 Injection in Renally Impaired Subjects
|
Phase 1 | |
| Completed |
NCT01407874 -
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
|
Phase 2 | |
| Completed |
NCT01172431 -
Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency
|
Phase 4 | |
| Completed |
NCT00765830 -
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)
|
Phase 3 | |
| Completed |
NCT00770081 -
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)
|
Phase 3 | |
| Completed |
NCT01545531 -
Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance
|
N/A | |
| Terminated |
NCT00338455 -
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
|
Phase 2 | |
| Completed |
NCT00159614 -
Effect of KW-3902IV in Combination With IV Furosemide on Renal Function in Subjects With CHF and Renal Impairment
|
Phase 2 | |
| Completed |
NCT02894385 -
Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)
|
Phase 1 | |
| Completed |
NCT02894905 -
A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335
|
Phase 1 | |
| Active, not recruiting |
NCT04876963 -
HOLT-ED: Holter-monitoring in End-stage Renal Disease
|
||
| Not yet recruiting |
NCT03899298 -
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
|
Phase 1 | |
| Completed |
NCT03235375 -
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects
|
Phase 1 | |
| Withdrawn |
NCT03329612 -
Remote Ischemic Preconditioning in ACS Patients
|
N/A | |
| Active, not recruiting |
NCT02598635 -
Effects of Cholecalciferol on Osteoprotegerin Levels in Patients on Peritoneal Dialysis
|
Phase 4 |