A Phase 2 interventional study of Fer-In-Sol and Shohl's solution in Iron-Refractory Iron-Deficiency Anemia, sponsored by Rockwell Medical Technologies, Inc.. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-22.
Sponsored by Rockwell Medical Technologies, Inc. · Phase 2, Interventional, and Treatment
The main purpose is to determine whether Triferic, administered orally with Shohl's solution, is safe and effective for the treatment of iron-refractory iron-deficiency anemia (IRIDA).
This is an open label, 3-period study assessing the safety, efficacy, and pharmacokinetics of Triferic and Shohl's solution administered orally to patients with IRIDA. A total of 28 patients stratified by 4 age groups (age 0 to \<6 years, age 6 to \<12 years, age 12 to \<18 years, and age >=18 years) will be studied.
Total participation in the study is between 4 weeks (Period 1) and 12 months (Periods 1, 2, and 3), depending upon how many Periods each patient participates in. Following screening, in Period 1 (iron absorption testing) patients undergo oral iron absorption testing during 3 visits to confirm that they adequately absorb iron from Triferic when it is administered with Shohl's solution ('Triferic responders': patients with a maximal increase from baseline in serum iron concentration >100 micrograms per deciliter (μg/dL) following an oral Shohl's solution and Triferic dose).
The 'Triferic responders' from Period 1 are then invited to participate in Period 2 (dose titration). The patients will receive Shohl's solution and Triferic orally up to 3 times per day for 4 months, titrated as needed based on laboratory results and patient tolerance, to determine whether their hemoglobin levels respond to this treatment. Period 2 'hemoglobin responders' (patients with an increase from baseline in hemoglobin (Hgb) concentration ≥1.0 grams per deciliter (g/dL) at Visit 9) will be invited to participate in period 3.
In Period 3 patients will receive Shohl's solution and Triferic orally up to 3 times per day for an additional 6 months to determine whether the hemoglobin response observed in Period 2 is sustainable. During Period 3, Shohl's solution and Triferic dose and frequency may continue to be titrated as needed based on laboratory results and patient tolerance.
A follow-up visit will occur approximately 1 week after the last completed Period study visit, regardless of the Period that the patient completes the study.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 1 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →Rockwell Medical Technologies, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
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Exclusion Criteria:
During 3 consecutive weekly study visits, patients will receive Fer-In- Sol orally 3 milligram iron per kilogram (mg Fe/kg) body weight, Shohl's solution 0.67 millimoles per kilogram (mmol/kg) followed 5 - 15 minutes later by Fer-In- Sol orally 3 mg Fe/kg body weight, and Shohl's solution 0.67 mmol/kg followed 5 - 15 minutes later by Triferic orally 3 mg Fe/kg body weight (respectively). All oral doses will be administered by study personnel at the research center. Blood tests will be conducted following each administration in order to measure iron absorption to see if patients qualify for Period 2.
Drug: Fer-In-Sol · Drug: Shohl's solution · Drug: Triferic
Patients who qualified as 'Triferic responders' in Period 1 will participate in Period 2. Patients will be given oral Shohl's solution and Triferic to administer at home 3 times per day, with the dose being titrated higher or lower based on lab results. The initial dose will be the same as Period 1 (Shohl's solution 0.67 mmol/kg followed 5 - 15 minutes later by Triferic orally 3 mg Fe/kg body weight) but may be adjusted during Period 2 based on lab results. Period 2 will involve 5 study visits, scheduled every 4 weeks. At the end of Period 2, blood tests will be performed to determine if patients qualify for Period 3.
Drug: Shohl's solution · Drug: Triferic
Patients who qualified as 'hemoglobin responders' in Period 2 will participate in Period 3. Patients will continue to take Shohl's solution and Triferic at their titrated dose for an additional six months to confirm that their hemoglobin can be maintained over an extended period of time. The period will be comprised of 3 study visits, scheduled every 8 weeks.
Drug: Shohl's solution · Drug: Triferic
Fer-In-Sol is an over-the-counter oral iron supplement. It will be administered during Period 1 at a dose of 3 mg/kg body weight.
Also known as: FeSO4
Shohl's solution will be supplied as 500-milliliter (mL) bottles containing citric acid United States Pharmacopeia (USP) 640 milligrams per 5 milliliters (mg/5 mL) and hydrous sodium citrate USP 490 mg/5 mL. It will be administered during all Periods at a dose of 0.67 mmol/kg body weight.
Also known as: Citrate, Oracit
Triferic is an iron salt that is approved by the Food and Drug Administration (FDA) for the maintenance of hemoglobin in patients with end stage kidney disease on hemodialysis. It is experimental in this study because it has not yet been approved for patients with IRIDA. It will be administered during Period 1 at a dose of 3 mg/kg body weight. In Periods 2 and 3 the dose may be adjusted based on lab results.
Also known as: ferric pyrophosphate citrate (FPC)
The Efficacy of Triferic Delivered to IRIDA Patients:Change in Hemoglobin (Hgb)
The efficacy will be done by assessing the change from baseline in hemoglobin concentration
Time frame: 4 months
The Efficacy of Triferic Being Delivered to Iron-refractory Iron Deficiency Anemia (IRIDA) Patients:Change in Serum Iron
The efficacy will be done by assessing the change from baseline in serum iron
Time frame: 4 months
The Efficacy of Triferic Being Delivered to IRIDA Patients:Change From Baseline in Transferrin Saturation (TSAT)
The efficacy will be done by assessing the change from baseline in TSAT
Time frame: 4 months
| Milestone | All Participants |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
The efficacy will be done by assessing the change from baseline in hemoglobin concentration
| micrograms per deciliter | All Patients in Study |
|---|---|
| The Efficacy of Triferic Delivered to IRIDA Patients:Change in Hemoglobin (Hgb) | 7.9 |
The efficacy will be done by assessing the change from baseline in serum iron
| micrograms per deciliter | All Patients in Study |
|---|---|
| The Efficacy of Triferic Being Delivered to Iron-refractory Iron Deficiency Anemia (IRIDA) Patients:Change in Serum Iron | 19 |
The efficacy will be done by assessing the change from baseline in TSAT
| micrograms per deciliter | All Patients in Study |
|---|---|
| The Efficacy of Triferic Being Delivered to IRIDA Patients:Change From Baseline in Transferrin Saturation (TSAT) | 6.2 |
Collected over 11 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | All Participants |
|---|---|
| Viral InfectionInfections and infestations | 1/1 |
| HalitosisGastrointestinal disorders | 1/1 |
| InfluenzaInfections and infestations | 1/1 |
| Age, Categorical(Participants) | All Patients in Study |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Patients in Study |
|---|---|
| Female | 1 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | All Patients in Study |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
No study locations are listed for this record.
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Plan to share: Yes
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Rockwell Medical Technologies, Inc.