A Phase 3 interventional study of FK506E in Heart Transplantation, Liver Transplantation and Kidney Transplantation, sponsored by Astellas Pharma Europe Ltd.. Completed at 105 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Astellas Pharma Europe Ltd. (part of Astellas Pharma Inc) · Phase 3, Interventional, and Treatment
The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.
The objective of this study was to asses the safety and efficacy of FK506E (MR4) as a long-term treatment in transplant recipients. Only patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of study medication were enrolled.
Astellas Pharma Europe Ltd. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single open arm of FK506E (MR4). Since this was an extension study for many studies, generally the dose given at enrollment was to be continued. The investigator was permitted to adjust the subject's dose and modify the MR4 dose regimen as deemed necessary to minimize Adverse Events (AEs) and maintain effective immunosuppression. MR4 capsules were taken orally, once daily in the morning. MR4 capsules were to be swallowed with fluid (preferably water) on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. MR4 was supplied as 0.5 mg, 1 mg and 5 mg capsules in amber glass bottles or in blister packs.
Drug: FK506E
oral
Also known as: Astagraf XL, Advagraf, Graceptor, MR4, Prograf XL
Participant Survival
Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood's formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .
Time frame: Up to 5.5 years (66 months (phase II) and 24 months (phase III)).
Graft Survival
Graft survival was analyzed using Kaplan-Meier Method procedures at 66 months (phase II) and 30 months (phase III). The two-sided 95% confidence intervals for the estimated rates of patients free from graft loss at EOS was calculated using Greenwood's formula. Graft loss was defined as re-transplantation or death. For kidney transplantation graft loss was also defined as nephrectomy or return to long-term dialysis. The date of graft loss is the earliest date of either of these events. Start, event and censor times for the Kaplan-Meier analyses of graft survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .
Time frame: Up to 5.5 years ((66 months (phase II) and 30 months (phase III)).
Biopsy-confirmed Acute Rejection (BCAR) Episodes
FAS population. Evaluation of biopsy specimens performed by local histopathologist following "Histological Grading of Biopsies for Rejection" using grading relevant to type of organ allograft. Spontaneously resolving AR defined as episode not treated with new/increased corticosteroid medication, antibodies/any other medication and resolved irrespective of any MR4/MMF/azathioprine dose changes; corticosteroid sensitive AR was an episode which was treated with new/increased corticosteroid medication only and resolved, irrespective of any MR4, MMF or azathioprine dose changes; corticosteroid resistant AR was an episode which did not resolve following treatment with corticosteroids, if it was not treated with corticosteroids first but only with antibodies, it was included in this category; corticosteroid resistant AR episodes were further classified into episodes which resolved with further treatment and those which did not respond to further treatment/were ongoing at EOS/withdrawal.
Time frame: Up to 6 years.
Time to First BCAR Episode
The time to first acute rejection episode was defined as the number of days from day 1 (defined as the day of study enrollment) to the first clinical, laboratory or histological signs that were considered to be related to the first acute rejection episode.
Time frame: Up to 1344 days (3.75 years).
Number of Participants With Adverse Events
An AE was defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have a causal relationship with treatment. An AE was, therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use the study drug, whether or not related to the study drug. Causally-related is defined as a highly probably, probably, possible, not assessable or missing relationship as assessed by the investigator. An SAE was any untoward medical occurrence that at any dose: Resulted in death, was life threatening: did not refer to event which hypothetically might have caused death if more severe); resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; required inpatient hospitalization/led to prolongation of hospitalization (treatment/observation/examination caused by AE was considered serious); other medically important events.
Time frame: From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).
This multicenter study was conducted in 128 centers in 24 countries worldwide. The Principal Investigator at each study site was a medical doctor experienced in the treatment of transplant participants.
| Milestone | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 47 | 47 | 67 | 79 | 130 | 191 | 85 | 107 | 88 | 9 |
| Completed | 30 | 32 | 53 | 55 | 113 | 163 | 83 | 105 | 84 | 7 |
| Not completed | 17 | 15 | 14 | 24 | 17 | 28 | 2 | 2 | 4 | 2 |
| Withdrew: Death | 4 | 0 | 4 | 6 | 3 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 5 | 4 | 4 | 5 | 5 | 9 | 1 | 1 | 4 | 0 |
| Withdrew: Consent withdrawn | 2 | 0 | 3 | 4 | 1 | 4 | 0 | 0 | 0 | 0 |
| Withdrew: Non-compliance | 2 | 1 | 1 | 5 | 0 | 1 | 0 | 1 | 0 | 0 |
| Withdrew: Pregnancy | 1 | 1 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 2 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Immunosuppressive regimen (not mr4) | 1 | 5 | 1 | 2 | 4 | 2 | 0 | 0 | 0 | 2 |
| Withdrew: Prohibited medication | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | 0 |
| Withdrew: Miscellaneous | 1 | 2 | 0 | 2 | 0 | 4 | 0 | 0 | 0 | 0 |
Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood's formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .
| survival probability | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| Participant Survival | 0.9092 (0.824 to 0.994) | 1.0000 (1.000 to 1.000) | 0.9356 (0.875 to 0.997) | 0.9031 (0.828 to 0.979) | 0.9536 (0.899 to 1.000) | 0.9933 (0.980 to 1.000) | 1.000 (1.000 to 1.000) | 1.000 (1.000 to 1.000) | 1.000 (1.000 to 1.000) | NA (NA to NA) |
Graft survival was analyzed using Kaplan-Meier Method procedures at 66 months (phase II) and 30 months (phase III). The two-sided 95% confidence intervals for the estimated rates of patients free from graft loss at EOS was calculated using Greenwood's formula. Graft loss was defined as re-transplantation or death. For kidney transplantation graft loss was also defined as nephrectomy or return to long-term dialysis. The date of graft loss is the earliest date of either of these events. Start, event and censor times for the Kaplan-Meier analyses of graft survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .
| survival probability | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| Graft Survival | 0.9092 (0.824 to 0.994) | 1.0000 (1.000 to 1.000) | 0.9217 (0.856 to .988) | 0.9031 (0.828 to 0.979) | 0.9536 (0.899 to 1.000) | 0.9469 (0.889 to 1.000) | 1.0000 (1.000 to 1.000) | 0.9898 (0.970 to 1.000) | 1.0000 (1.000 to 1.000) | NA (NA to NA) |
FAS population. Evaluation of biopsy specimens performed by local histopathologist following "Histological Grading of Biopsies for Rejection" using grading relevant to type of organ allograft. Spontaneously resolving AR defined as episode not treated with new/increased corticosteroid medication, antibodies/any other medication and resolved irrespective of any MR4/MMF/azathioprine dose changes; corticosteroid sensitive AR was an episode which was treated with new/increased corticosteroid medication only and resolved, irrespective of any MR4, MMF or azathioprine dose changes; corticosteroid resistant AR was an episode which did not resolve following treatment with corticosteroids, if it was not treated with corticosteroids first but only with antibodies, it was included in this category; corticosteroid resistant AR episodes were further classified into episodes which resolved with further treatment and those which did not respond to further treatment/were ongoing at EOS/withdrawal.
| participants with with BCAR episodes | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| BCAR episodes | 3 | 3 | 0 | 9 | 5 | 1 | 0 | 0 | 1 | 0 |
| In male subjects N=36,27,48,64,91,117,61,80,52,5 | 2 | 1 | 0 | 9 | 3 | 0 | 0 | 0 | 1 | 0 |
| In female subjects N=11,20,19,15,39,74,24,27,36,4 | 1 | 2 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
| BCAR episodes with spontaneous resolution | 1 | 0 | 0 | 4 | 2 | 0 | 0 | 0 | 0 | 0 |
| Corticosteriod sensitive BCAR episodes | 2 | 2 | 0 | 5 | 3 | 1 | 0 | 0 | 0 | 0 |
| Corticosteroid resistant BCAR episodes | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Mild histological grade of BCAR episodes | 2 | 1 | 0 | 4 | 2 | 1 | 0 | 0 | 0 | 0 |
| Moderate histological grade of BCAR episodes | 0 | 2 | 0 | 4 | 2 | 0 | 0 | 0 | 1 | 0 |
| Severe histological grade of BCAR episodes | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Unknown histological grade of BCAR episodes | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
The time to first acute rejection episode was defined as the number of days from day 1 (defined as the day of study enrollment) to the first clinical, laboratory or histological signs that were considered to be related to the first acute rejection episode.
| days | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| Time to First BCAR Episode | 479.3 ± 634.5 | 358 ± 350.8 | — | 601.2 ± 405.8 | 89.6 ± 148.4 | 1 ± 0 | — | — | 192 ± 0 | — |
An AE was defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have a causal relationship with treatment. An AE was, therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use the study drug, whether or not related to the study drug. Causally-related is defined as a highly probably, probably, possible, not assessable or missing relationship as assessed by the investigator. An SAE was any untoward medical occurrence that at any dose: Resulted in death, was life threatening: did not refer to event which hypothetically might have caused death if more severe); resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; required inpatient hospitalization/led to prolongation of hospitalization (treatment/observation/examination caused by AE was considered serious); other medically important events.
| participants with adverse events | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse events | 47 | 47 | 67 | 73 | 130 | 180 | 58 | 59 | 62 | 1 |
| Causally related adverse events | 47 | 42 | 44 | 56 | 112 | 132 | 33 | 29 | 21 | NA |
| Serious adverse events | 36 | 31 | 40 | 43 | 67 | 64 | 13 | 16 | 15 | 2 |
| Causally related serious adverse events | 22 | 16 | 15 | 21 | 31 | 30 | 5 | 7 | 2 | NA |
| Deaths | 4 | 0 | 4 | 6 | 3 | 1 | 0 | 0 | 0 | 0 |
Efficacy failure was defined as BCAR, graft loss, death, or an unknown outcome at the end of the study period. Start, event and censor times for the Kaplan-Meier analyses of efficacy failure were (Event time: onset of first episode of BCAR, graft loss, or death after study start, Censor Time: day of withdrawal (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study). No Kaplan-Meier estimates for PMR-EC-1210 due to the short subject participation period and the low number of subjects
| participants with efficacy failure | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| Failure during the study | 6 | 3 | 5 | 15 | 8 | 6 | 0 | 1 | 1 | 0 |
| Failure after withdrawal | 1 | 2 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Failure cause during study: BCAR | 3 | 3 | 0 | 9 | 5 | 2 | 0 | 0 | 1 | 0 |
| :Acute respiratory failure | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Astrocytoma | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Chronic allograft dysfunction | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| :Hepatic cirrhosis | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Hypoglycemia | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Increased creatinine | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Cerebrovascular accident | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Lymphoma | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Lung neoplasm | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Operative hemorrhage | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Pulmonary embolism | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Renal insufficiency | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Sudden death | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| :Cardiac disorder | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| :Hepatic insufficiency | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| :Hemolytic/uremic syndrome | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| :Esophageal varices hemorrhage | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| :Urethral stenosis | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Failure cause after withdrawal: Lost to follow-up | 1 | 2 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
Collected over From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FG-506-11-01 | — | 36/47 (76.6%) | 47/47 (100%) |
| FG-506E-12-01 | — | 31/47 (66%) | 47/47 (100%) |
| FG-506E-12-02 | — | 40/67 (59.7%) | 66/67 (98.5%) |
| FG-506-15-02 | — | 43/79 (54.4%) | 73/79 (92.4%) |
| FG-506E-11-03 | — | 67/130 (51.5%) | 129/130 (99.2%) |
| FG-506E-12-03 | — | 64/191 (33.5%) | 175/191 (91.6%) |
| PMR-EC-1105 | — | 13/85 (15.3%) | 52/85 (61.2%) |
| PMR-EC-1205 | — | 16/107 (15%) | 54/107 (50.5%) |
| PMR-EC-1209 | — | 15/88 (17%) | 60/88 (68.2%) |
| PMR-EC-1210 | — | 2/9 (22.2%) | 1/9 (11.1%) |
| Event | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infection bacterialInfections and infestations | 0/47 | 9/47 | 2/67 | 0/79 | 0/130 | 7/191 | 0/85 | 1/107 | 1/88 | 0/9 |
| Bile duct stenosisHepatobiliary disorders | 6/47 | 0/47 | 0/67 | 0/79 | 6/130 | 0/191 | 0/85 | 0/107 | 0/88 | 0/9 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/47 | 0/47 | 1/67 | 1/79 | 0/130 | 0/191 | 0/85 | 0/107 | 0/88 | 1/9 |
| Blood creatinine increasedInvestigations | 1/47 | 3/47 | 2/67 | 0/79 | 0/130 | 3/191 | 0/85 | 0/107 | 0/88 | 1/9 |
| Laryngeal papillomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/47 | 0/47 | 0/67 | 0/79 | 0/130 | 0/191 | 0/85 | 0/107 | 0/88 | 1/9 |
| Abdominal painGastrointestinal disorders | 4/47 | 0/47 | 0/67 | 0/79 | 2/130 | 1/191 | 0/85 | 0/107 | 1/88 | 0/9 |
| Cytomegalovirus infectionInfections and infestations | 1/47 | 3/47 | 0/67 | 0/79 | 0/130 | 1/191 | 1/85 | 1/107 | 0/88 | 0/9 |
| Hepatitis CInfections and infestations | 3/47 | 0/47 | 0/67 | 0/79 | 8/130 | 0/191 | 0/85 | 0/107 | 0/88 | 0/9 |
| GastroenteritisInfections and infestations | 1/47 | 2/47 | 4/67 | 0/79 | 0/130 | 3/191 | 1/85 | 0/107 | 2/88 | 0/9 |
| CellulitisInfections and infestations | 0/47 | 0/47 | 0/67 | 4/79 | 1/130 | 1/191 | 0/85 | 0/107 | 0/88 | 0/9 |
| Event | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 |
|---|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infection bacterialInfections and infestations | 4/47 | 19/47 | 10/67 | 3/79 | 4/130 | 28/191 | 2/85 | 2/107 | 1/88 | 0/9 |
| HypertensionVascular disorders | 19/47 | 11/47 | 13/67 | 19/79 | 50/130 | 41/191 | 13/85 | 6/107 | 4/88 | 0/9 |
| NasopharyngitisInfections and infestations | 9/47 | 16/47 | 3/67 | 15/79 | 7/130 | 12/191 | 0/85 | 1/107 | 4/88 | 1/9 |
| LeukopeniaBlood and lymphatic system disorders | 14/47 | 5/47 | 0/67 | 1/79 | 11/130 | 5/191 | 0/85 | 0/107 | 0/88 | 1/9 |
| DiarrhoeaGastrointestinal disorders | 9/47 | 8/47 | 5/67 | 23/79 | 12/130 | 24/191 | 2/85 | 3/107 | 12/88 | 0/9 |
| HyperuricaemiaMetabolism and nutrition disorders | 4/47 | 13/47 | 1/67 | 0/79 | 12/130 | 13/191 | 8/85 | 0/107 | 0/88 | 0/9 |
| TremorNervous system disorders | 11/47 | 13/47 | 1/67 | 3/79 | 8/130 | 13/191 | 1/85 | 0/107 | 3/88 | 1/9 |
| HyperglycaemiaMetabolism and nutrition disorders | 12/47 | 5/47 | 0/67 | 2/79 | 7/130 | 17/191 | 3/85 | 2/107 | 1/88 | 0/9 |
| Renal insufficiencyRenal and urinary disorders | 12/47 | 1/47 | 0/67 | 7/79 | 25/130 | 0/191 | 2/85 | 0/107 | 0/88 | 0/9 |
| Back painMusculoskeletal and connective tissue disorders | 5/47 | 5/47 | 3/67 | 20/79 | 14/130 | 7/191 | 1/85 | 2/107 | 1/88 | 0/9 |
The baseline analysis population consisted of the Full Analysis Set (FAS) population. The FAS included all subjects who received at least one dose of study drug, MR4, while participating in one of the phase II PK or phase III studies and at least one dose of MR4 during this study.
| Age, Continuous(years) | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 47.9 ± 9.5 | 44.0 ± 11.6 | 44.7 ± 12.4 | 51.3 ± 11.4 | 53.9 ± 8.4 | 46.9 ± 12.1 | 53.2 ± 10.3 | 49.4 ± 12.1 | 53.8 ± 11.1 | 36 ± 13.3 | 49.6 ± 11.7 |
| Sex: Female, Male(Participants) | FG-506-11-01 | FG-506E-12-01 | FG-506E-12-02 | FG-506-15-02 | FG-506E-11-03 | FG-506E-12-03 | PMR-EC-1105 | PMR-EC-1205 | PMR-EC-1209 | PMR-EC-1210 | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 36 | 27 | 48 | 64 | 91 | 117 | 61 | 80 | 52 | 5 | 581 |
| Male | 11 | 20 | 19 | 15 | 39 | 74 | 24 | 27 | 36 | 4 | 269 |
Showing the first 100 of 105 sites across 23 countries. Choose a country and city above to see the rest.
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tacrolimus