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The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). It is an open label, dose escalation study.
This is a phase 1, open-label, dose escalation study assessing the pharmacokinetic (PK) profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered intraperitoneally in chronic kidney disease patients on peritoneal dialysis (Continuous Cycling Peritoneal Dialysis (CCPD) or Continuous Ambulatory Peritoneal Dialysis (CAPD)).
Screening can be up to 4 weeks, and the enrollment period is approximately one week. There are two treatment (dosing) visits and one follow-up visit during the enrollment period.
At each treatment visit, the patients will be randomly assigned to receive either a single ascending dose of Triferic administered intraperitoneal (IP) during a long (12 hour) peritoneal dialysis dwell or a single 6.6 mg dose of Triferic administered IV over 4 hours. Blood samples will be obtained at defined times over 12 hours to establish the total serum iron PK of IP Triferic as well as the clinical serum iron profile.
The IP dose of the first Cohort will be 5 mg Triferic iron/liter IP. Subsequent Cohort IP doses will be 12.5 mg Triferic iron/liter, and 20 mg Triferic iron/liter, with the final Cohort dose to be determined (TBD). The IV dose will be 6.6. mg for all Cohorts. Six patients will be enrolled in each Cohort, with enrollment in the subsequent (higher dose) Cohort not being initiated until the completion and evaluation of the previous (lower dose) Cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single dose of Triferic in the peritoneal dialysis solution | Experimental | The patient will receive a single dose of Triferic in the peritoneal dialysis solution (IP) during a long (12 hour) peritoneal dialysis dwell. Each Cohort will receive a different ascending IP dose ( 5 mg/L, 12.5 mg/L, 20 mg/L). Blood samples will be drawn periodically over a 12 hour period for analysis. |
|
| single IV dose of Triferic 6.6 mg over a 4 hour period | Experimental | The patient will receive a single 6.6 mg intravenous (IV) dose of Triferic in the over a 4 hour period. All Cohorts will receive the same IV dose. Blood samples will be drawn periodically over a 12 hour period for analysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triferic | Drug | Triferic is an iron salt that is approved by the 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 on chronic peritoneal dialysis. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic | The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
| Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intraperitoneal Administration of Triferic | The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
| Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0 - 12 of Serum Total Iron After Intraperitoneal Administration of Triferic | The PK will be done by assessing the AUC from time zero to 12 hours after infusion (AUC0-12) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
| Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic | The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
| Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intravenous Administration of Triferic |
| Measure | Description | Time Frame |
|---|---|---|
| Bioavailability of Triferic Iron Administered Via PD Solution: F(Cmax) | The bioavailability (F) of the maximum serum iron concentration (Cmax) of Triferic iron was quantified for the peritoneal dialysis dose of Triferic for all cohorts. | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond D Pratt, MD, FACP | Rockwell Medical, Inc | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| FG001 | Cohort 2 | Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| FG002 | Cohort 3 | Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| FG003 | Cohort 4 | Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| FG004 | Cohort 5 | Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| BG001 | Cohort 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic | The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per deciliter | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
|
Adverse events data was collected from the date of enrollment through the completion of the follow-up study visit. This timeframe was approximately 5 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Patients in Cohort 1 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| clinical project manager | Rockwell Medical | 248-960-9009 | sgrimberg@rockwellmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 21, 2016 | Aug 29, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 26, 2017 | Aug 29, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| C049051 | ferric pyrophosphate |
| C032360 | spleen fibrinolytic proteinase (human) |
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|
The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). |
| 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
| Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0-12 of Serum Total Iron After Intravenous Administration of Triferic | The PK will be done by assessing the AUC from time zero to 12 hours after the infusion (AUC0-12) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| BG002 | Cohort 3 | Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| BG003 | Cohort 4 | Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| BG004 | Cohort 5 | Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| OG002 | Cohort 3 | Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| OG003 | Cohort 4 | Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
| OG004 | Cohort 5 | Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. |
|
|
| Primary | Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intraperitoneal Administration of Triferic | The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | Posted | Geometric Mean | Geometric Coefficient of Variation | hours x micrograms/ deciliters | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
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| Primary | Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0 - 12 of Serum Total Iron After Intraperitoneal Administration of Triferic | The PK will be done by assessing the AUC from time zero to 12 hours after infusion (AUC0-12) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | Posted | Geometric Mean | Geometric Coefficient of Variation | hours x micrograms/ deciliters | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
|
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| Primary | Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic | The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/ deciliters | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
|
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| Primary | Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intravenous Administration of Triferic | The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | Posted | Geometric Mean | Geometric Coefficient of Variation | hours* micrograms/ deciliters | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
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| Primary | Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0-12 of Serum Total Iron After Intravenous Administration of Triferic | The PK will be done by assessing the AUC from time zero to 12 hours after the infusion (AUC0-12) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). | Posted | Geometric Mean | Geometric Coefficient of Variation | hours* micrograms/ deciliters | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours |
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| Secondary | Bioavailability of Triferic Iron Administered Via PD Solution: F(Cmax) | The bioavailability (F) of the maximum serum iron concentration (Cmax) of Triferic iron was quantified for the peritoneal dialysis dose of Triferic for all cohorts. | Posted | Geometric Mean | Geometric Coefficient of Variation | percent of bioavailability | 12 hours |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Cohort 2 | Patients in Cohort 2 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 12.5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Cohort 3 | Patients in Cohort 3 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic7. 5 mg Fe/L in Dianeal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG003 | Cohort 4 | Patients in Cohort 4 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Cohort 5 | Patients in Cohort 5 received 2 doses of Triferic in a randomized, cross-over design. The doses were Triferic 2.5 mg Fe/L in Extraneal PD solution and Triferic 6.6 mg Fe via 4-hour IV infusion, with 48 hours separating the start of each dose. | 0 | 6 | 0 | 6 | 0 | 6 |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
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| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |