HypotensionPhase 2NCT00448071
Pharmacokinetic and Pharmacodynamic Effects of MTR107 in End-Stage Renal Disease (ESRD) Patients
A Phase 2 study testing MTR107 in people with Hypotension and End Stage Renal Disease, run by Wolfson Medical Center at 2 sites in Israel.
Trial summary
MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent Intra dialytic Hypotension Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension
- What is being tested?
- MTR107
- How many people
- 12 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-75 years, inclusive.
- 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.
- ECG performed up to one month before study start.
- 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),
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- Serum aminotransferases (AST (0-37 U/L) and ALT (0-40 U/L)),
- GGT (Gamma Glutamine Trans Peptidase)
- Normal coagulation status at study entry as judged by PT-INR, PTT, fibrinogen and platelet count.
- Willingness to participate in the study and adhere to the study design.
- Willingness to sign an informed consent form.
Who cannot join
- Uncontrolled hypertension >140/90 mmHg.
- Unstable angina.
- Abnormal ECG which may indicate acute disease
- Variable weight gains.
- Mental retardation.
- Pregnancy.
- Malignancy or other concomitant serious diseases.
- Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.
Trial locations and contacts
2 sites in 1 country.
Zeev Katzir, MD contact
Israel2 sites, 2 recruiting
- Recruiting
Wolfson Medical Center
Holon, 58100
Zeev Katzir, MD, 972-3-5028291, katzir@wolfson.health.gov.il
Zeev Katzir, MD
- Recruiting
Asaf Harofeh Medical Center
Rishon LeZiyyon, 70300
Shay Efrati, MD, 972-8-9778061
Shay Efrati, MD
About this study
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
Read the detailed description
The present clinical trial aims to investigate and provide a more precise characterization of the pharmacokinetic and pharmacodynamic profile of MTR107 in a population of ESRD patients predisposed to developing intradialytic hypotension. The study is also designed as a dose esclating study aiming to assess MTR107 safety.
- Being tested
- MTR107
- Keywords
- Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension, ESRD, Blood Pressure, Dialysis
- Medical subject headings
- Hypotension, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTR107Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.
Secondary outcomes (4)
Exploratory Efficacy Parameters:
Number and type of medical interventions required for treatment of hypotension.
Alleviation of symptoms associated with intradialytic hypotension.
Efficiency of dialysis as reflected by Kt/V
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startMay 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Collaborators
- Meditor Pharmaceuticals Ltd.
- Investigators
- Zeev Katzir, MD, Principal investigator, Wolfson Medical CenterShay Efrati, MD, Principal investigator, Asaf Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448071
- Sponsor's protocol ID
- MTR107IL-104
- Status last verified
- Dec 2006
- First submitted
- 14 Mar 2007
- Last updated
- 15 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00448071
- Acronym / sponsor ID
- MTR107IL-104
- Keywords
- Hypotension, End Stage Renal Disease, Intra Dialytic Hypotension, ESRD, Blood Pressure, Dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants
- Lead sponsor
- Wolfson Medical CenterOther government
- Collaborators
- Meditor Pharmaceuticals Ltd.
- Study start
- May 2006
- Study completion
- Mar 2007
- First posted
- 15 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MTR107 effect on blood pressure throught the dialysis procedure and its ability to prevent Intra dialytic Hypotension
Detailed description
The present clinical trial aims to investigate and provide a more precise characterization of the pharmacokinetic and pharmacodynamic profile of MTR107 in a population of ESRD patients predisposed to developing intradialytic hypotension. The study is also designed as a dose esclating study aiming to assess MTR107 safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 20-75 years, inclusive.
- 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.
- ECG performed up to one month before study start.
- Well-preserved hepatic function (within normal laboratory ranges) at study entry as judged by:
- Normal coagulation status at study entry as judged by PT-INR, PTT, fibrinogen and platelet count.
Key exclusion criteria (8 listed)
- Uncontrolled hypertension >140/90 mmHg.
- Unstable angina.
- Abnormal ECG which may indicate acute disease
- Variable weight gains.
- Mental retardation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTR107 | Drug | – |
Primary outcome
A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.
4 secondary outcomes
Exploratory Efficacy Parameters:
Number and type of medical interventions required for treatment of hypotension.
Alleviation of symptoms associated with intradialytic hypotension.
Efficiency of dialysis as reflected by Kt/V
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeev Katzir, MD contact
Zeev Katzir, MD principal investigator
Wolfson Medical Center
Shay Efrati, MD principal investigator
Asaf Harofeh Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTR107 in people with Hypotension and End Stage Renal Disease, run by Wolfson Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeev Katzir, MD (972-3-5028211), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A descriptive pharmacokinetic / pharmacodynamic study. No primary end-points apply.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2007.