End Stage Renal Disease Clinical Trial
Official title:
A Phase II, Randomized Double Blind Placebo-Controlled, Dose Escalating Study to Determine Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients
MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent Intra dialytic Hypotension
Status | Recruiting |
Enrollment | 12 |
Est. completion date | March 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Age 20-75 years, inclusive. 2. Presence of frequent bouts of hypotension defined as 3 or more intradialytic hypotensive events per month for the last six months prior to baseline, despite standard adjustments in dry weight. 3. ECG performed up to one month before study start. 4. Well-preserved hepatic function (within normal laboratory ranges) at study entry as judged by: - Serum Bilirubin (Total Bilirubin (direct and indirect) 0.3-1.0 mg/dL, and Direct Bilirubin 0.1-0.5 mg/dL) - Serum Albumin (>3.6 g/dL), - Serum aminotransferases (AST (0-37 U/L) and ALT (0-40 U/L)), - GGT (Gamma Glutamine Trans Peptidase) 5. Normal coagulation status at study entry as judged by PT-INR, PTT, fibrinogen and platelet count. 6. Willingness to participate in the study and adhere to the study design. 7. Willingness to sign an informed consent form. Exclusion Criteria: 1. Uncontrolled hypertension >140/90 mmHg. 2. Unstable angina. 3. Abnormal ECG which may indicate acute disease 4. Variable weight gains. 5. Mental retardation. 6. Pregnancy. 7. Malignancy or other concomitant serious diseases. 8. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Wolfson Medical Center | Holon | |
Israel | Asaf Harofeh Medical Center | Rishon Le Zion |
Lead Sponsor | Collaborator |
---|---|
Wolfson Medical Center | Meditor Pharmaceuticals Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply. | |||
Secondary | Exploratory Efficacy Parameters: | |||
Secondary | ? Number and type of medical interventions required for treatment of hypotension. | |||
Secondary | ? Alleviation of symptoms associated with intradialytic hypotension. | |||
Secondary | ? Efficiency of dialysis as reflected by Kt/V |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04076488 -
Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases
|
N/A | |
Completed |
NCT03289650 -
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
|
Phase 3 | |
Completed |
NCT04042324 -
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01242904 -
Use of a Bimodal Solution for Peritoneal Dialysis
|
Phase 2 | |
Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
Completed |
NCT03257410 -
Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
|
N/A | |
Completed |
NCT03627299 -
Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors
|
Phase 4 | |
Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
Terminated |
NCT03539861 -
Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients
|
N/A | |
Withdrawn |
NCT02130817 -
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
|
Phase 4 | |
Completed |
NCT05540457 -
Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis)
|
N/A | |
Not yet recruiting |
NCT04900610 -
The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis
|
N/A | |
Recruiting |
NCT02176434 -
Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease
|
N/A | |
Active, not recruiting |
NCT02581449 -
Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis
|
Phase 2 | |
Completed |
NCT02134314 -
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
|
Phase 1/Phase 2 | |
Completed |
NCT02832440 -
Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis
|
N/A | |
Completed |
NCT02215655 -
Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence
|
N/A | |
Completed |
NCT02830490 -
Reliability of Functional Measures in Hemodialysis Patient.
|
N/A | |
Completed |
NCT02832466 -
Quantifying the Deterioration of Physical Function in Renal Patients
|
N/A | |
Recruiting |
NCT01912001 -
Virtual Ward for Home Dialysis
|
N/A |