Anemia, Sickle CellPhase 2NCT00276146
Dipyridamole/Magnesium To Improve Sickle Cell Hydration
A Phase 2 study testing oral dipyridamole, oral magnesium, or a combination of both in people with Anemia, Sickle Cell, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.
Trial summary
The purpose of this study is to determine the benefits as well as side effects of giving drugs called dipyridamole and magnesium to patients with sickle cell anemia (SCA). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Anemia, Sickle Cell
- What is being tested?
- oral dipyridamole, oral magnesium, or a combination of both
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2005to not given
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients with homozygous sickle cell (Hb SS) confirmed by hemoglobin electrophoresis or HPLC
- Patients with adequate cardiac, renal, and liver function
- Patients with baseline fetal hemoglobin (Hb F) level of 10% or less
- Patients with at least 6% dense cells or higher at initial screening visit
- Patients with no history of coronary heart disease
- Patients with normal baseline ECG
- Patients with no history of hypotension or hypotensive episodes
Who cannot join
- Patients who are pregnant, trying to become pregnant, or breast feeding
- Patients who are on a chronic transfusion program
- Patients who are unable to take oral medications
- Patients who have significant cardiac, renal, or liver dysfunction
- Patients who are on hydroxyurea
- Patients who have a fetal hemoglobin (Hgb F) level of greater than 10%, or have less than 6% dense cell on initial screen
Show all 15Show fewer
- Patients who are taking a supplement which contains magnesium
- Patients who are taking aspirin, ibuprofen on a daily basis, or anti-coagulant such as Coumadin on a daily basis
- Patients who have a known underlying coagulopathy (acquired or congenital) or have prolonged PT or PTT at the time of initial screen
- Patients who have had a hypersensitivity to either of the study medications
- Patients who are taking any other study medication(s). Patients will not be excluded if they are on penicillin prophylaxis or folic acid, or use ibuprofen intermittently
- Patients taking tetracycline or sodium polystyrene sulfonate
- Patients on concomitant medications and other therapy must have a wash out period prior to study entry and/or study drug dosing
- Patients with abnormal baseline ECG
- Patients with a history of hypotension or hypotensive episodes
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinnati
Cincinnati, Ohio, 45219
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
The purpose of this study is to determine the benefits as well as side effects of giving drugs called dipyridamole and magnesium to patients with sickle cell anemia (SCA).
Read the detailed description
Vaso-occlusive episodes are the most common problem experienced by patients with SCA and the most frequent reason for hospital admissions as well as visits to the clinic and emergency department. Many cellular, humoral, and vascular factors influence the initiation and propagation of vaso-occlusion by sickle cells. Among these is the tendency of sickle cells (SS RBC) to become dehydrated with accompanying increase in the hemoglobin (Hb) concentration. Since sickle hemoglobin (Hb S) concentration controls the rate of polymerization, cellular dehydration plays a key role in sickle cell pathology.
Two separate but interdependent cation transport mechanisms affect sickle cell hydration, the first involving abnormal KCl cotransport (KCC), and the second a sickle-induced (SI) passive leak which permits the influx of calcium ions (Ca++) that activates the Gardos pathway, a Ca++-dependent K channel. Early investigations aimed at inhibiting KCC with magnesium (Mg) and the Gardos pathway with clotrimazole met with partial success. We have recently shown in vitro that dipyridamole also inhibits the SI pathway. Strategies designed to block the formation of these dense, dehydrated cells would offer important therapeutic options that might decrease the number and severity of the vaso-occlusive episodes in patients. Drawing on the information gained from two decades of research on cation transport in SS RBC, including the unique discovery made at this Center that dipyridamole inhibits the SI cation leak, we now propose a study of combined therapy using two transport inhibitors aimed at reducing SS RBC dehydration.
- Conditions
- Anemia, Sickle Cell
- Being tested
- oral dipyridamole, oral magnesium, or a combination of both
- Keywords
- dipyridamole, magnesium, sickle cell, anemia, red blood cells
- Medical subject headings
- Anemia, Sickle Cell, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral dipyridamole, oral magnesium, or a combination of bothDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess effects on red cell hydration.
To assess effects on red cell survival. Measurements will be performed before and after treatment.
Secondary outcomes (2)
To monitor side effects of each treatment arm.
To evaluate clinical outcomes during each phase of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startMay 2005
Why it stopped: The NHLBI BSMB recommended closure due to poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Kalinyak, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276146
- Sponsor's protocol ID
- CCHMC 03-7-41
- Other IDs
- U54HL070871
- Status last verified
- Aug 2013
- First submitted
- 11 Jan 2006
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipyridamole/Magnesium To Improve Sickle Cell Hydration
- ClinicalTrials.gov ID
- NCT00276146
- Acronym / sponsor ID
- CCHMC 03-7-41
- Conditions
- Anemia, Sickle Cell
- Keywords
- dipyridamole, magnesium, sickle cell, anemia, red blood cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The NHLBI BSMB recommended closure due to poor enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- May 2005
- First posted
- 13 Jan 2006 (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.
The purpose of this study is to determine the benefits as well as side effects of giving drugs called dipyridamole and magnesium to patients with sickle cell anemia (SCA).
Detailed description
Vaso-occlusive episodes are the most common problem experienced by patients with SCA and the most frequent reason for hospital admissions as well as visits to the clinic and emergency department. Many cellular, humoral, and vascular factors influence the initiation and propagation of vaso-occlusion by sickle cells. Among these is the tendency of sickle cells (SS RBC) to become dehydrated with accompanying increase in the hemoglobin (Hb) concentration. Since sickle hemoglobin (Hb S) concentration controls the rate of polymerization, cellular dehydration plays a key role in sickle cell pathology.
Two separate but interdependent cation transport mechanisms affect sickle cell hydration, the first involving abnormal KCl cotransport (KCC), and the second a sickle-induced (SI) passive leak which permits the influx of calcium ions (Ca++) that activates the Gardos pathway, a Ca++-dependent K channel. Early investigations aimed at inhibiting KCC with magnesium (Mg) and the Gardos pathway with clotrimazole met with partial success. We have recently shown in vitro that dipyridamole also inhibits the SI pathway. Strategies designed to block the formation of these dense, dehydrated cells would offer important therapeutic options that might decrease the number and severity of the vaso-occlusive episodes in patients. Drawing on the information gained from two decades of research on cation transport in SS RBC, including the unique discovery made at this Center that dipyridamole inhibits the SI cation leak, we now propose a study of combined therapy using two transport inhibitors aimed at reducing SS RBC dehydration.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with homozygous sickle cell (Hb SS) confirmed by hemoglobin electrophoresis or HPLC
- Patients with adequate cardiac, renal, and liver function
- Patients with baseline fetal hemoglobin (Hb F) level of 10% or less
- Patients with at least 6% dense cells or higher at initial screening visit
- Patients with no history of coronary heart disease
Key exclusion criteria (15 listed)
- Patients who are pregnant, trying to become pregnant, or breast feeding
- Patients who are on a chronic transfusion program
- Patients who are unable to take oral medications
- Patients who have significant cardiac, renal, or liver dysfunction
- Patients who are on hydroxyurea
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 |
|---|---|---|
| oral dipyridamole, oral magnesium, or a combination of both | Drug | – |
Primary outcome
To assess effects on red cell hydration.
To assess effects on red cell survival. Measurements will be performed before and after treatment.
2 secondary outcomes
To monitor side effects of each treatment arm.
To evaluate clinical outcomes during each phase of the study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Sickle Cell Center at Cincinnati Children's Hospital Medical CenterLink provided by the sponsor.
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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.
Karen Kalinyak, MD principal investigator
Children's Hospital Medical Center, Cincinnati
3 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 oral dipyridamole, oral magnesium, or a combination of both in people with Anemia, Sickle Cell, run by Children's Hospital Medical Center, Cincinnati at 3 sites in United States.
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 7 inclusion and 15 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: withdrawn, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess effects on red cell hydration.. The study lists 2 primary outcomes in all. 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 7 Aug 2013.