β-thalassemiaPhase 1NCT00560820
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
A Phase 1 study testing Deferasirox in people with β-thalassemia and Transfusional Iron Overload, run by Novartis Pharmaceuticals at 3 sites in Italy.
Trial summary
The primary purpose of this study is to evaluate the effect of deferasirox on renal hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and filtration fraction (FF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- β-thalassemia, Transfusional Iron Overload
- What is being tested?
- Deferasirox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2007to Apr 2012
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years of age without prior history of deferasirox treatment
- β-thalassemia patients receiving regular transfusions every 2-5 weeks
- Transfusion history of ≥ 20 units of packed red blood cells
Who cannot join
- Abnormal renal function at baseline
- ALT greater than 5 x ULN at screening
- Patients with underlying cardiac disease requiring continuous iron chelation therapy
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Novartis Investigative Site
Cagliari, CA, 09121
Novartis Investigative Site
Genova, GE, 16128
Novartis Investigative Site
Orbassano, 10043
About this study
The primary purpose of this study is to evaluate the effect of deferasirox on renal hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and filtration fraction (FF).
- Conditions
- β-thalassemia, Transfusional Iron Overload
- Being tested
- Deferasirox
- Keywords
- β-thalassemia, transfusional iron overload, renal function, renal biomarkers, deferasirox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeferasiroxDrug
Also called ICL670
30 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Deferasirox | Experimental | 30 mg/kg/day Receives: Drug: Deferasirox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.
Measured: Once a month
Secondary outcomes (1)
Effect of deferasirox on standard markers of renal function
Measured: Once a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for β-thalassemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560820
- Sponsor's protocol ID
- CICL670A2123
- Other IDs
- 2006-006838-17
- Status last verified
- Jun 2016
- First submitted
- 19 Nov 2007
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Piga A, Fracchia S, Lai ME, Cappellini MD, Hirschberg R, Habr D, Wegener A, Bouillaud E, Forni GL. Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent beta thalassaemia. Br J Haematol. 2015 Mar;168(6):882-90. doi: 10.1111/bjh.13217. Epub 2014 Nov 17.
PubMed 25402221
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
- ClinicalTrials.gov ID
- NCT00560820
- Acronym / sponsor ID
- CICL670A2123
- Conditions
- β-thalassemia, Transfusional Iron Overload
- Keywords
- β-thalassemia, transfusional iron overload, renal function, renal biomarkers, deferasirox
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Nov 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.
The primary purpose of this study is to evaluate the effect of deferasirox on renal hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and filtration fraction (FF).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deferasirox | Experimental | Drug: Deferasirox30 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients ≥ 18 years of age without prior history of deferasirox treatment
- β-thalassemia patients receiving regular transfusions every 2-5 weeks
- Transfusion history of ≥ 20 units of packed red blood cells
Key exclusion criteria (4 listed)
- Abnormal renal function at baseline
- ALT greater than 5 x ULN at screening
- Patients with underlying cardiac disease requiring continuous iron chelation therapy
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| DeferasiroxAlso: ICL67030 mg/kg/day | Drug | Deferasirox |
Primary outcome
Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.
Time frame: Once a month
1 secondary outcome
Effect of deferasirox on standard markers of renal function
Time frame: Once a month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Derived from this study: PubMed 25402221Piga A, Fracchia S, Lai ME, Cappellini MD, Hirschberg R, Habr D, Wegener A, Bouillaud E, Forni GL. Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent beta thalassaemia. Br J Haematol. 2015 Mar;168(6):882-90. doi: 10.1111/bjh.13217. Epub 2014 Nov 17.
- Results for CICL670A2123 can be found on the Novartis Clinical Trials Results WebsiteLink 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deferasirox in people with β-thalassemia and Transfusional Iron Overload, run by Novartis Pharmaceuticals at 3 sites in Italy.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Dec 2020. 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 Italy. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload. (time frame: Once a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00560820, which also lists 1 linked publication.
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 9 Dec 2020.