Renal Insufficiency Clinical Trial
Official title:
A Clinical Study of the Living-related Renal Transplantation With Restored Kidneys (Interventional Trial)
Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die
every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000
patients are registered with the Japan Organ Transplant Network (JOTN) with the hope for a
renal transplantation. If the renal function is restored by transplantation, the quality of
life (QOL) improves and more than 90% are reportedly comeback to their normal life
activities and get relieved from the burden of dialysis. Furthermore, it can reduce the
dialysis related medical cost by as much as 50%. However, only about 1,000 renal
transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal
transplantations offered by family members or relatives, and the rest are from deceased
donors.
Due to the fact that the number of deceased donors are scarce and only living renal
transplantations between the family members or relatives are currently allowed in Japan, the
approximate waiting time to receive a renal transplantation is 16 years. For that reason,
many patients travel abroad to receive a renal transplantation.
There are reports that total nephrectomies are performed as a treatment for small size (4 cm
or less) renal tumors, renal stones, ureteral tumors and ureteral strictures in many cases
and that many of these nephrectomized kidneys can be successfully transplanted after
surgical restoration with satisfactory results. However, due to the lack of necessary
evidence it is currently not allowed in Japan.
Therefore, the investigators planned the present clinical study to evaluate the curative
efficacy (renal function, QOL) and safety (side effects, complications or occurrence of
renal cancer) of living renal transplantations between family members and relatives with
restored donor kidneys after the surgical removal or repairment of a small size (4 cm or
less) renal tumor or renal stone, ureteral tumor or ureteral stricture, in order to acquire
necessary clinical data for potential enrichment of the renal donor pool in Japan as well as
to develop useful medical care for our patients who are on dialysis for many years due to
the renal failure.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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 |
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 |
NCT01462136 -
PK Study of ACHN-490 Injection in Renally Impaired Subjects
|
Phase 1 | |
| 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 |
NCT01545531 -
Two-Point Measurement of Glomerular Filtration Rate by Iohexol Plasma Disappearance
|
N/A | |
| 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 | |
| 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 | |
| Recruiting |
NCT02578784 -
DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis
|
N/A |