Clinical trials: Kidney Transplant; Complications
Renal Failure
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly…
- Trial name
- LCPTacro3002 (NCT01187953)
- Testing
- Prograf (tacrolimus), LCP-Tacro
- Where
- 86 sites in United States, Argentina and 13 more
- Volunteers
- 543 people
- Sponsor
- Veloxis Pharmaceuticals
End-stage Renal Disease, Kidney Failure, Chronic
Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
- Trial name
- NCT01840956
- Testing
- HAVG
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Humacyte, Inc.
End Stage Renal Disease
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
- Trial name
- NCT02165761
- Testing
- GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- W.L.Gore & Associates
Fanconi Anemia Complementation Group A, Fanconi Anemia
Long-Term Follow-up of Subjects With Fanconi Anaemia Subtype A Treated With ex Vivo Gene Therapy
This is a long-term safety and efficacy follow-up study for subjects with Fanconi Anaemia Subtype A who have been treated with ex vivo gene therapy on the FANCOLEN-I trial.
- Trial name
- NCT04437771
- Testing
- Safety and efficacy assessments
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- Rocket Pharmaceuticals Inc.
End Stage Renal Disease
Evaluation of STARgraft AV for Hemodialysis Access
This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft.
- Trial name
- NCT03916731
- Testing
- STARgraft AV, ePTFE AV graft (control)
- Where
- Paraguay
- Volunteers
- 55 people
- Sponsor
- Healionics Corporation
End Stage Renal Disease
Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease
The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.
- Trial name
- NCT07696962
- Testing
- ChoironeX GalKO Porcine Thymokidney
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Xeno Holdings (US), LLC dba ChoironeX
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Kidney Transplant Rejection
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
- Trial name
- NCT06126380
- Testing
- AT-1501, Tacrolimus
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 132 people
- Sponsor
- Eledon Pharmaceuticals
Kidney Transplant Rejection, End Stage Renal Disease
Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
- Trial name
- NCT05987527
- Testing
- Blood sample
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 11 people
- Sponsor
- Sangamo Therapeutics
Stenosis, Restenosis
Clinical Study of the BARD® COVERA™ Arteriovenous (AV) Stent Graft
The objective of this study is to assess the safety and effectiveness of the COVERA™ Vascular Covered Stent for the treatment of stenotic lesions in the upper extremity venous outflow of the Arteriovenous (AV) access circuit.
- Trial name
- AVeNEW (NCT02649946)
- Testing
- Covera Vascular Covered Stent following PTA, Percutaneous Transluminal Angioplasty (PTA) with Uncoated PTA Balloon
- Where
- 24 sites in United States, Australia and 6 more
- Volunteers
- 280 people
- Sponsor
- C. R. Bard
Chronic Kidney Disease
Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease
IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor specific antibodies to reduce the antibody load and thus enable kidney transplantation.
- Trial name
- NCT02224820
- Testing
- IdeS
- Where
- Sweden
- Volunteers
- 8 people
- Sponsor
- Hansa Biopharma AB
Anemia, Iron-Deficiency, Kidney Failure, Chronic
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents…
- Trial name
- NCT00224042
- Testing
- Sodium Ferric Gluconate complex in sucrose, Ferrous sulfate tablets
- Where
- 24 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Watson Pharmaceuticals
End Stage Renal Disease (ESRD), Kidney Failure
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD).
- Conditions
- End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease, Hemodialysis
- Trial name
- NCT04671771
- Testing
- InnAVasc Arteriovenous Graft (IG) surgical implant
- Where
- 22 sites in United States
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Clostridium Difficile Infection Recurrence
Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II.
- Trial name
- PRISM3 (NCT03110133)
- Testing
- Full Spectrum Microbiota
- Where
- 58 sites in United States, Canada
- Volunteers
- 206 people
- Sponsor
- Finch Research and Development LLC.
Chronic Kidney Disease
A Study of PRT-201 Administered After Arteriovenous Graft (AVG) Creation in Patients With Chronic Kidney Disease
PRT-201 is a recombinant human type-I pancreatic elastase intended for local, long-lasting dilation of the AVG venous anastomosis and outflow vein.
- Trial name
- PRT-201-102 (NCT01001351)
- Testing
- PRT-201
- Where
- 16 sites in United States
- Volunteers
- 89 people
- Sponsor
- Proteon Therapeutics
Congestive Heart Failure, Cardiac Transplantation
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor (nesiritide).
- Conditions
- Congestive Heart Failure, Cardiac Transplantation, Renal Insufficiency, Renal Failure
- Trial name
- NCT00338455
- Testing
- Natrecor (nesiritide)+Standard Care+dobutamine or milrinone
- Where
- 14 sites in United States
- Volunteers
- 16 people
- Sponsor
- Scios, Inc.
Kidney Transplantation
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.
- Trial name
- ADHERE (NCT01363752)
- Testing
- Advagraf, Mycophenolate Mofetil, Sirolimus
- Where
- 58 sites in Australia, Austria and 15 more
- Volunteers
- 853 people
- Sponsor
- Astellas Pharma Inc
End Stage Renal Disease
A Pilot Study To Evaluate The CreatiVasc Hemoaccess Valve System In Patients Requiring Arteriovenous Graft Placement
The ability to selectively control blood flow through an arteriovenous (AV) graft only when it is needed for dialysis may reduce the current repetitive complications such as thrombosis, venous hypertension post-dialysis bleeding…
- Trial name
- NCT01644526
- Testing
- Hemoaccess Valve System
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Diaxamed LLC
Chronic Kidney Diseases, End Stage Renal Disease on Dialysis
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis.
- Trial name
- AVG22-09 (NCT05846581)
- Testing
- GORE® ACUSEAL Vascular Graft
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 72 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Disease
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving…
- Trial name
- ACUSEAL (NCT01173718)
- Testing
- GORE® ACUSEAL Vascular Graft
- Volunteers
- 138 people
- Sponsor
- W.L.Gore & Associates