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| Name | Class |
|---|---|
| CTI Clinical Trial and Consulting Services | OTHER |
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A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
Stable kidney transplant patients who fulfill all I/E criteria will be enrolled and kept on Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf, all patients will be converted to once daily LCP-Tacro for 7 days with no dose changes allowed. On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will be converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCP-Tacro (tacrolimus) | Active Comparator | Experimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCP Tacro (tacrolimus) | Drug | Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses. Other Names: Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Steady State Tacrolimus Trough Levels (C24). | Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro. | 7 days |
| Evaluation of Steady State Tacrolimus Exposure (AUC 0-24). | Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro. | 7 days |
| Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24). | Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured. | 21 days |
| Evaluation of Steady State Tacrolimus Exposure (AUC 0-24). | Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours). | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21. | Cmax and Cavg was measured at day 21 (Cmin was measured as part of the primary outcome). | 21 days |
| Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Glicklich, MD | Veloxis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States | ||
| Methodist Hospital Houston |
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| ID | Title | Description |
|---|---|---|
| FG000 | LCP-Tacro | All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15. On Day 22 patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days. LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LCP-Tacro | LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL. |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21. | Cmax and Cavg was measured at day 21 (Cmin was measured as part of the primary outcome). | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit. The arithmetic mean and standard deviation is given. | Posted | Mean | Standard Deviation | ng/mL | 21 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 | LCP-Tacro | LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL. 60 patients were enrolled into the study, but only 51 were dosed with LCP-Tacro. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Sylvest, Sr VP, Global Clinical Development and Operations | Veloxis A/S | +45 20553877 | csy@veloxis.com |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
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| Prograf | Drug | Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses. Other Names: Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets. |
|
|
Tmax was measured at day 21 (Cmin was measured as part of the primary outcome).
| 21 days |
| Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21. | Degree og fluctuation and degree of swing was measured at day 21 (Cmin was measured as part of the primary outcome). | 21 days |
| Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7. | Cmax and Cavg was measured at baseline day 7 (Cmin was measured as part of the primary outcome). | 7 days |
| Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7. | Tmax was measured at baseline day 7 (Cmin was measured as part of the primary outcome). | 7 days |
| Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7. | Degree og fluctuation and degree of swing was measured as baseline at day 7 (Cmin was measured as part of the primary outcome). | 7 days |
| Safety Evaluation | A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety. | 52 days |
| Houston |
| Texas |
| 77030 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21. | Tmax was measured at day 21 (Cmin was measured as part of the primary outcome). | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit. | Posted | Mean | Full Range | hour | 21 days |
|
|
|
| Secondary | Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21. | Degree og fluctuation and degree of swing was measured at day 21 (Cmin was measured as part of the primary outcome). | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit. Arithmetic mean and standard deviation is given below. | Posted | Mean | Standard Deviation | percentage | 21 days |
|
|
|
| Primary | Evaluation of Steady State Tacrolimus Trough Levels (C24). | Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro. | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. The arithmetic mean and standard deviation is given. | Posted | Mean | Standard Deviation | ng/mL | 7 days |
|
|
|
| Primary | Evaluation of Steady State Tacrolimus Exposure (AUC 0-24). | Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro. | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. The arithmetic mean and standard deviation is given. | Posted | Mean | Standard Deviation | ng*hr/mL | 7 days |
|
|
|
| Primary | Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24). | Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured. | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit. The arithmetic mean and standard deviation is given. | Posted | Mean | Standard Deviation | ng/mL | 21 days |
|
|
|
| Primary | Evaluation of Steady State Tacrolimus Exposure (AUC 0-24). | Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours). | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit. The arithmetic mean and standard deviation is given. | Posted | Mean | Standard Deviation | ng*hr/mL | 21 days |
|
|
|
| Secondary | Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7. | Cmax and Cavg was measured at baseline day 7 (Cmin was measured as part of the primary outcome). | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. The arithmetic mean and standard deviation is given. | Posted | Mean | Standard Deviation | ng/mL | 7 days |
|
|
|
| Secondary | Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7. | Tmax was measured at baseline day 7 (Cmin was measured as part of the primary outcome). | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit. | Posted | Mean | Full Range | hour | 7 days |
|
|
|
| Secondary | Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7. | Degree og fluctuation and degree of swing was measured as baseline at day 7 (Cmin was measured as part of the primary outcome). | 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Arithmetic mean and standard deviation is given below. | Posted | Mean | Standard Deviation | percentage | 7 days |
|
|
|
| Secondary | Safety Evaluation | A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety. | All enrolled patients are included in the safety population. | Posted | Number | participants | 52 days |
|
|
|
| 2 |
| 51 |
| 35 |
| 51 |
| EG001 | Prograf | Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL. 60 patients were entrolled into the study and one withdrew consent right after screening. Therefore 59 patients are inlcuded in the ITT safety set. | 0 | 59 | 19 | 59 |
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary casts | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dsypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Application site irritation | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Conjunctuvitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Poor venous access | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Immunosuppressant drug level increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gatroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
The study is a multicenter collaborative investigation and the clinical trial results are to be published as a collaborative manuscript. Authorship will reflect varying levels of individual contribution to the study by the individual PI's.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
|