EUCTR2017-003029-14-GB进行中（未招募）1 期
A phase 3b, multicenter, prospective, randomized, double blind, placebocontrolled study to reduce incidence of pre-dialysis hyperkalemia with Sodium Zirconium Cyclosilicate (DIALIZE) - DIALIZE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Female or male aged = 18 years at screening Visit 1. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
- •3. Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of end-stage renal disease (ESRD) for at least 3 months before randomization.
- •4. Patients must have hemodialysis access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study.
- •5. Pre-dialysis serum K >5.4 mmol/L after long inter-dialytic interval and >5.0 mmol/L after one short inter-dialytic interval during screening (as assessed by central lab).
- •6. Prescribed dialysate K concentration = 3 mmol/L during screening
- •7. Sustained Qb =200 ml/min and spKt/V =1.2 (or URR = 63) on stable hemodialysis/hemodiafltration prescription during screening with prescription (time, dialyzer, blood flow [Qb], dialysis flow rate [Qd] and bicarbonate concentration) expected to remain unchanged during study
- •8. Heparin dose (if used) must be stable during screening and expected to be stable during the study.
- •9. Subjects must be receiving dietary counselling appropriate for ESRD patients treated with hemodialysis/ hemodiafiltration as per local guidelines, which includes dietary potassium restriction.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca, including ZS Pharma staff and/or staff at the study site)
- •2. Hemoglobin <9 g/dL on screening (as assessed on Visit 1)
- •3. Lack of compliance with hemodialysis prescription (both number and duration of treatments) during the two-week period preceding screening (100% compliance required)
- •4. Patients treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS, Resonium calcium) or patiromer (Veltassa) within 7 days before screening or anticipated in requiring any of these agents during the study
- •5. Myocardial infarction, acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 12 weeks prior to randomization
- •6. Laboratory diagnosis of hypokalemia (K < 3.5 mmol/L), hypocalcemia (Ca < 8.2 mg/dL; for Japan hypocalcaemia is defined as albumin - corrected Ca < 8.0 mg/dL), hypomagnesemia (Mg < 1.7 mg/dL) or severe acidosis (serum bicarbonate 16 mEq/L or less) in the 4 weeks preceding randomization
- •7. Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable).
- •8. Severe leukocytosis (>20× 10^9/L) or thrombocytosis (=450 × 10^9/L) during screening
- •9. Polycythemia (Hb >14 g/dL) during screening
- •10. Diagnosis of rhabdomyolysis during the 4 weeks preceding randomization
- •11. Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug
- •12. Patients unable to take oral ZS drug mix
- •13. Scheduled date for living donor kidney transplant
- •14. Patients with a life expectancy of less than 6 months
- •15. Female patients who are pregnant or breastfeeding
- •16. Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence
- •17. Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
- •18. Participation in another clinical study with an investigational product during the last 1 month before screening
- •19. Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound safety or efficacy assessment and jeopardize the quality of the data, or may interfere with study participation
- •20. Presence of cardiac arrhythmias or conduction defects that require immediate treatment
- •21. History of alcohol or drug abuse within 2 years prior to randomization
- •22. Previous randomization in the present study
研究者
相似试验
已完成
3 期
DIALIZEHyperkalemiaJPRN-jRCT2080223796AstraZeneca45
进行中（未招募）
1 期
A phase III, multicentre, prospective, randomized, assessor-blinded, two-arm, parallel group, therapeutic non-inferiority 3-month clinical trial to compare the efficacy and safety of a generic fixed combination of brinzolamide 10 mg/mL + brimonidine tartrate 2 mg/mL eye drops suspension (Pharmathen) versus SIMBRINZA®/Alcon 10 mg/mL + 2 mg/mL eye drops suspension in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertensioOpen-angle glaucoma (OAG) or ocular hypertension (OHT)MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2020-000079-18-GRPharmathen S.A.200
尚未招募
3 期
A Phase 3, multi-center, prospective, randomized, double-blind, placebo- controlled study to evaluate the effectiveness and safety of ZP5-9676 for the treatment of Hookworm (Ancylostoma duodenale and Necator americanus), Ascaris lumbricoides, and Trichuris trichiura in pediatric and adult ParticipantsSoil-Transmitted HelminthiasisPACTR202404505131714Zero Point Five Therapeutics300
招募中
1 期
Study to identify the most appropriate therapy for patients with Acute Myeloid Leukemia carrying FLT3 mutation, using the PBC biomarker to customize therapy.Acute Myeloid Leukemia (LMA) with FLT3 mutationMedDRA version: 21.1Level: PTClassification code: 10000880Term: Acute myeloid leukaemia Class: 100000004864CTIS2023-505901-17-00Fondazione Gimema Franco Mandelli Onlus172
进行中（未招募）
1 期
A prospective, phase III, multicenter, randomized, investigator-masked, parallel groups, non-inferiority clinical trial for the comparison of efficacy and safety and of a generic fixed combination of Brinzolamide 10mg/ml / Timolol 5 mg/ml eye drops suspension versus Azarga®/ALCON 10mg/ml – 5mg/ml eye drops suspension in subjects with open angle glaucoma or ocular hypertension.open-angle glaucoma or ocular hypertensionMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersEUCTR2019-000921-39-CYPHARMATHEN SA216