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NCT ID: NCT04968184 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD

Clarion-CKD
Start date: November 5, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [eGFR {EPI}] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.

NCT ID: NCT04963270 Active, not recruiting - Clinical trials for Generalized Myasthenia Gravis

A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

Start date: October 19, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

NCT ID: NCT04959032 Active, not recruiting - Schizophrenia Clinical Trials

Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Start date: July 8, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).

NCT ID: NCT04956692 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)

Start date: August 5, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.

NCT ID: NCT04950127 Active, not recruiting - Pruritus Clinical Trials

Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.

NCT ID: NCT04948333 Active, not recruiting - Clinical trials for Chronic Myelogenous Leukemia

Asciminib Treatment Optimization in ≥ 3rd Line CML-CP.

Start date: October 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs). Patients for this study will be identified based on warning criteria and resistance definition following European Leukemia Network (ELN) 2020 recommendations. In addition, the study will investigate the use of two different posologies. For this, patients will receive asciminib 40 mg (twice-daily) BID or of 80 mg (once daily) once daily (QD).

NCT ID: NCT04947020 Active, not recruiting - Rectal Cancer Clinical Trials

dataBase for Analysis of Rectal Cancer Oncological Results

BARO
Start date: August 1, 2021
Phase:
Study type: Observational

The data will be obtained from 10 tertiary centers located in Poland (Cracow - coordinating center, Warsaw - 3 centers, Sosnowiec, Szczecin, Bydgoszcz, Lublin, Gdansk, Poznan) and 5 foreign centers. The analyses will include patients with rectal cancer operated on between 2013-2019. A database in MS Excel is prepared that consists of following data: - Type of neoadjuvant treatment (if any) - Time-interval between the end of neoadjuvant treatment and surgery - Type of surgery - Staging of rectal cancer i.e. (y)pTNM - Number of retrieved lymph nodes - Number of lymph nodes with metastases - R classification (R0, R1, R2) - Preoperative medications (metformin, statins, NSAIDs, anticoagulants) - Recurrence date and type (local, systemic, both diagnosed at the same time) - Date of death or date of last follow-up visit The aims of the study are following: 1. Establishing whether neoadjuvant treatment (PSCR or chemoradiotherapy) influences number of retrieved lymph nodes in rectal cancer 2. Establishing whether time-interval between the end of PSCR and surgery influences lymph node yield 3. Establishing the prognostic value of lymph node ratio - validation of the previously calculated cutoff point at the level of 0.41 4. Determining independent prognostic factors in rectal cancer - in particular related to medications taken before the operation, metformin and anti diabetic drugs in the first place

NCT ID: NCT04938817 Active, not recruiting - Clinical trials for Small Cell Lung Carcinoma

Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)

Start date: August 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a rolling arm study of pembrolizumab in combination with investigational agents in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study.

NCT ID: NCT04934800 Active, not recruiting - Multiple Sclerosis Clinical Trials

Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)

Start date: December 10, 2019
Phase:
Study type: Observational

The main aim is to study in the real world setting the effectiveness of Cladribine tablets in terms of Annualized Relapse Rate (ARR) and disability progression, in participants who switched from a first line Disease Modifying Drug (DMD) (Interferons, Glatiramer Acetate, Teriflunomide, (Dymethyl fumarate) [DMF]) to treatment with Cladribine tablets in routine clinical practice.

NCT ID: NCT04933721 Active, not recruiting - Clinical trials for Hereditary Angioedema

Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

APeX-A
Start date: July 23, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.