Polycystic Kidney Diseases Clinical Trial
Official title:
An Open-label, Prospective Clinical Trial to Evaluate the Effectiveness and Safety of Sirolimus to Reduce Cyst Growth in ADPKD Patients With Massive Polycystic Liver
The purpose of this study is to evaluate the effectiveness and safety of Sirolimus in reducing liver volume in autosomal dominant polycystic kidney disease.
Autosomal dominant polycystic kidney disease (ADPKD) is one of the most common causes of end stage renal disease (ESRD), affecting an estimated 0.2% of population. Of ADPKD patients, 58% in 15-24 year, 85% in 25-34 year, and 94% in 35-46 year olds suffer from polycystic liver in addition to polycystic kidneys. Several anti-proliferative drugs have been used in clinical trials to stop cyst growth both in liver and kidneys. Among them, octreotide and sirolimus have been shown to be one of the most promising drugs to reduce cyst volume. Sirolimus already has been used as one of the most potential oral immunosuppressants. Moreover, the serum trough level is quite easy to measure. Sirolimus is the mTOR inhibitor that has been proven to be effective in reducing cyst growth both in animal models. However, its efficacy and safety is not well proven in previous studies. This is a open-label, prospective study to evaluate the effectiveness and safety of Sirolimus to reduce cyst growth in ADPKD patients with massive polycystic liver. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04039061 -
ADPKD Patient Registry
|
||
| Enrolling by invitation |
NCT05215964 -
The Association Between Skeletal Muscle Mass and Severity of Polycystic Liver Disease and Polycystic Kidney Disease
|
||
| Completed |
NCT00286156 -
Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06036992 -
Study and Management of Cystic Complications in Autosomal Dominant Polycystic Kidney Disease
|
||
| Terminated |
NCT01009957 -
Everolimus on CKD Progression in ADPKD Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT01931644 -
At-Home Research Study for Patients With Autoimmune, Inflammatory, Genetic, Hematological, Infectious, Neurological, CNS, Oncological, Respiratory, Metabolic Conditions
|
||
| Completed |
NCT02739750 -
Pioglitazone and Lumbar Bone Marrow Fat in Chronic Kidney Disease
|
||
| Completed |
NCT03889392 -
Evaluation of Nephrectomy Specimen for Intracranial Aneurysm Development in ADPKD
|
||
| Completed |
NCT03948113 -
Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network).
|
||
| Recruiting |
NCT03726463 -
Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD
|
||
| Completed |
NCT03423810 -
Assessing a Dose‐Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients
|
Early Phase 1 |