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A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients with Mild to Moderate Renal Impairment

The primary objective of this study is:- To evaluate the effect of the elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) single-tablet regimen (STR) on renal parameters at Week 24The secondary objectives of this study are:- To…

A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Primary Objective: To characterize the long-term safety and tolerability of AMG 416 in the treatment of SHPT in subjects with CKD on hemodialysisSecondary Objective: To characterize the long-term efficacy of AMG 416 on intact parathyroid hormone (…

A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease

The primary objective of this trial is to evaluate and describe the long-term safety of tolvaptan.

An Open-label Trial Investigating the Association Between Nocturia Symptoms and Sleep During 12 Weeks of Treatment with desmopressin ODT for Nocturia due to Nocturnal Polyuria in Adults

Primary Objective* To assess the association between changes in the number of nocturnal voids and change in Nocturia Sleep Quality Scale (NSQS) total score in adult subjects with nocturia due to Nocturnal Polyuria (NP)Secondary Objectives* To assess…

A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

Objective: The principal objective is To evaluate the long-term safety and maintenance of efficacy of BOTOX® (200 U) injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have…

An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB)

To evaluate the safety and efficacy of solifenacin succinate suspension once daily in children and adolescents with OAB.

A Multicenter single-arm Extension Study to Describe the Long-term Safety
of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With
Chronic Kidney Disease on Hemodialysis.

Primary: characterize the long-term safety and tolerability of AMG 416 in the treatment of secondary hyperparathyroidism (SHPT) in subjects with chronic kidney disease (CKD) on hemodialysis.Secondary: to characterize intact parathyroid hormone (iPTH…

Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The objective of this extension study is to find out the potential long-term benefits and safety of tolvaptan. During this study all participants will receive tolvaptan.PRIMARY OBJECTIVE is to demonstrate whether tolvaptan modifies ADPKD progression…

A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO)

To evaluate the efficacy, safety and PK of solifenacin succinate suspension after multiple dose administration.

A multi-center, parallel-group, comparative trial evaluating the efficacy, pharmacokinetics and safety of 4.0 mg.kg-1 sugammadex administered at 1-2 PTC in subjects with normal or severely impaired renal function

Objective is to show equivalence with respect to the efficacy of sugammadex in subjects with normal or severely impaired renal function, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

An Open-label (OL) Extension Study evaluating the Long-Term Safety of OxabactTM in Subjects with Primary Hyperoxaluria (PH) who participated in the Double-Blind (DB) Efficacy Study

Primary Objective:To evaluate the Safety of OxabactTM with continued exposure.Secondary Objectives:To obtain additional efficacy data with up to 48 weeks continuous exposure to Oxabact*.

Transurethral Ultrasound directed Injection of autologous Myoblasts, Fibroblasts and Collagen for the treatment of urinary incontinence

The objective of the study is to ascertain whether the high effect sizes obtained in the previous studies can be explained according to our working hypothesis, i.e. whether the intervention with Urocell is associated with a structural regeneration…

A Multicenter, Open-Label Study of doxercalciferol capsules for the Treatment of Secondary Hyperparathyroidisms (SHPT) in Stage 3 or Stage 4 Chronic kidney Disease (CKD) Patients

Primary Objective: To evaluate the safety and tolerability of Hectorol Capsules during 52 weeks of treatment in patients with Stage 3 or Stage 4 CKDSecondary Objective: To evaluate the efficacy of Hectorol Capsules during 52 weeks of treatment in…

BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age

To evaluate the safety and efficacy of BOTOX for the treatment of urinary incontinencedue to overactive bladder (OAB) in patients 12 to 17 years of age who have not been adequately managed with anticholinergic therapy. To evaluate the safety and…

Multicenter, open-label, extension study to characterize the long-term efficacy and safety of early versus delayed treatment with venglustat (GZ/SAR402671) in patients at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD)

The aim of the follow-up study is to determine the differences between early versus late treatment with GZ / SAR402671 in the effect on total kidney volume growth (total kidney volume, TKV) and in the effect on slowing down renal impairment (change…

Effect of dapaglifozin on serum magnesium in HNF1β patients with renal hypomagnesemia

This study has been transitioned to CTIS with ID 2024-518855-43-00 check the CTIS register for the current data. Primary objective: To evaluate the effect of SGLT2 inhibition with dapagliflozin 10 mg on serum magnesium in diabetic and non-diabetic…

An 18-month, open-label, single-arm safety extension study of an age-and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria

This study has been transitioned to CTIS with ID 2023-504885-50-00 check the CTIS register for the current data. A study to learn more about how safe the study treatment finerenone is inlong-term use when taken with an ACE inhibitor or angiotensin…

An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

This study has been transitioned to CTIS with ID 2024-512260-54-00 check the CTIS register for the current data. PrimaryTo evaluate the effect of DCR PHXC on estimated glomerular filtration rate (eGFR) in participants with PH1Secondary:To identify…

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

Primary Objectives:Associated pharmaceutical trial:To compare the efficacy of disitamab vedotin in combination with pembrolizumab to chemotherapy as first-line treatment in subjects with advanced UC that expresses HER2Clinical performance study:To…

An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis.

Primary objectives: - Describe the safety of daprodustat, overall (all ages) and in each age group.Secondary objectives:- Describe changes in other parameters relevant to safety, overall and in each age group.- Describe the effect of daprodustat on…