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After enrolment was complete, and sufficient data was collected to fully characterize the highest dose cohort, study follow up was terminated by the sponsor for non-safety related reasons.
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The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Arm 2 | Experimental | TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Arm 3 | Experimental | TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Arm 4 | Experimental | TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCD601 | Biological | Investigational Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0. | 12 months | |
| Measure Peak TCD601 Plasma Concentration (Cmax) Over Time. | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration. | 12 months |
| Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC). | The AUC from time zero to the last measurable concentration sampling time. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Allograft Rejection at 12 Months Post-Transplant | 12 months | |
| To Assess Renal Function Over Time | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Fredrik Juhlin | ITB-Med LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck Medical University | Innsbruck | A-6020 | Austria | |||
| University of Vienna |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| FG001 | Arm 2 | TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| FG002 | Arm 3 | TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| FG003 | Arm 4 | TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| FG004 | Arm 5 | ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One participant was randomized, but never received Study Drug and was never received any study procedure during their screening period. Baseline characteristics were collected.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| BG001 | Arm 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 | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0. | Posted | Count of Participants | Participants | 12 months |
|
12 Months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | 27.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jesse Scott | ITB-MED LLC | 623174897 | jscott@nefro-avillion.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 6, 2024 | Feb 20, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2024 | Feb 20, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C544394 | siplizumab |
| D016559 | Tacrolimus |
| D000305 | Adrenal Cortex Hormones |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D006728 | Hormones |
| D006730 |
Not provided
Not provided
Not provided
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| Arm 5 | Active Comparator | ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
| Tacrolimus (TAC) | Drug | Standard of Care Concomitant Immunosuppression |
|
| Corticosteroids (CS) | Drug | Standard of Care Concomitant Immunosuppression |
|
| Mycophenolate Mofetil (MMF) | Drug | Standard of Care Concomitant Immunosuppression |
|
| ATG | Drug | Standard of Care induction therapy in solid organ transplantation |
|
| Vienna |
| 1090 |
| Austria |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitari de Bellvitge | Barcelona | 08907 | Spain |
| Karolinska University Hospital | Stockholm | Huddinge | 14157 | Sweden |
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| Skåne University Hospital | Malmö | 20502 | Sweden |
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
| BG002 | Arm 3 | TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| BG003 | Arm 4 | TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| BG004 | Arm 5 | ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | Kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Viral Serology | Viral Serology was collected prior to randomization, not at screening. One participant who was not treated with study drug after randomization was not collected. | Count of Participants | Participants |
|
| End Stage Disease leading to Transplantation | Count of Participants | Participants |
|
| Current Dialysis | Count of Participants | Participants |
|
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| OG003 | Arm 4 | TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
| OG004 | Arm 5 | ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). |
|
|
| Primary | Measure Peak TCD601 Plasma Concentration (Cmax) Over Time. | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration. | Participants enrolled in Arm 5, Control, are not included in this Outcome Measure because they were not assessed for PK parameters of Siplizumab. | Posted | Mean | Standard Deviation | ug/mL | 12 months |
|
|
|
| Primary | Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC). | The AUC from time zero to the last measurable concentration sampling time. | Participants enrolled in Arm 5, Control, are not included in this Outcome Measure because they were not assessed for PK parameters of Siplizumab. | Posted | Mean | Standard Deviation | ug/mLxday | 12 months |
|
|
|
| Secondary | The Incidence of Allograft Rejection at 12 Months Post-Transplant | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | To Assess Renal Function Over Time | The sponsor made the decision to terminate the clinical trial for non safety-related reasons prior to all Arm 4 Subjects completing Month 12 post-transplant. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 12 months |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| 6 |
| 6 |
| EG001 | Arm 2 | TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). | 0 | 5 | 1 | 5 | 5 | 5 |
| EG002 | Arm 3 | TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). | 0 | 8 | 4 | 8 | 8 | 8 |
| EG003 | Arm 4 | TCD601 5.0mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). | 0 | 8 | 4 | 8 | 8 | 8 |
| EG004 | Arm 5 | ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). | 0 | 5 | 0 | 5 | 5 | 5 |
| Pancreatitis | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Transplant Rejection | Immune system disorders | 27.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Pulmonary Nocardiosis | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Pneuomonia | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Cerebral Nocardiosis | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Delayed Graft Function | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Graft Thrombosis | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Infusion Related Reaction | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Renal Lymphocele | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Blood Creatinine Increased | Investigations | 27.1 | Non-systematic Assessment |
|
| New onset Diabetes after transplantation | Metabolism and nutrition disorders | 27.1 | Non-systematic Assessment |
|
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.1 | Non-systematic Assessment |
|
| Focal Segmental Glomerulosclerosis | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | 27.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | 27.1 | Non-systematic Assessment |
|
| Lymphocele | Vascular disorders | 27.1 | Non-systematic Assessment |
|
| Iron Deficiency Anemia | Blood and lymphatic system disorders | 27.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | 27.1 | Non-systematic Assessment |
|
| Nephrogenic Anemia | Blood and lymphatic system disorders | 27.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | 27.1 | Non-systematic Assessment |
|
| Polycythaemia | Blood and lymphatic system disorders | 27.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | 27.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | 27.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | 27.1 | Non-systematic Assessment |
|
| Hyperparathyroidism tertiary | Endocrine disorders | 27.1 | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | 27.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | 27.1 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | 27.1 | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | 27.1 | Non-systematic Assessment |
|
| scleral hemorrhage | Eye disorders | 27.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Intra-abdominal haematoma | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 27.1 | Non-systematic Assessment |
|
| chills | General disorders | 27.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | 27.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | 27.1 | Non-systematic Assessment |
|
| Malaise | General disorders | 27.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | 27.1 | Non-systematic Assessment |
|
| Pain | General disorders | 27.1 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | 27.1 | Non-systematic Assessment |
|
| Puncture site haematoma | General disorders | 27.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | 27.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | 27.1 | Non-systematic Assessment |
|
| Transplant Rejection | Immune system disorders | 27.1 | Non-systematic Assessment |
|
| BK virus infection | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Bacterial disease carrier | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Bacteriuria | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Epstein-Barr viraemia | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Genital herpes | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Lyme disease | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Nasal herpes | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Oral fungal infection | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Polyomavirus viraemia | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Suspected COVID-19 | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Transmission of an infectious agent via product | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | 27.1 | Non-systematic Assessment |
|
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Complications of transplanted kidney | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Drain site complication | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Incision site swelling | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Renal lymphocele | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | 27.1 | Non-systematic Assessment |
|
| Anti factor VIII antibody increased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood albumin decreased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood bicarbonate decreased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood magnesium decreased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood phosphorus decreased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood phosphorus increased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | 27.1 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | 27.1 | Non-systematic Assessment |
|
| C-reactive protein increased | Investigations | 27.1 | Non-systematic Assessment |
|
| Epstein-Barr virus antibody positive | Investigations | 27.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | 27.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | 27.1 | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | 27.1 | Non-systematic Assessment |
|
| Mycobacterium tuberculosis complex test positive | Investigations | 27.1 | Non-systematic Assessment |
|
| Renal function test abnormal | Investigations | 27.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | 27.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | 27.1 | Non-systematic Assessment |
|
| Acidosis | Investigations | 27.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Investigations | 27.1 | Non-systematic Assessment |
|
| Fluid retention | Investigations | 27.1 | Non-systematic Assessment |
|
| Folate deficiency | Investigations | 27.1 | Non-systematic Assessment |
|
| Glucose tolerance impaired | Investigations | 27.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hyperlipasaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hypernatraemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hyperphosphataemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hyperuricaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hypokalaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hyponatraemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Hypoproteinaemia | Investigations | 27.1 | Non-systematic Assessment |
|
| Metabolic acidosis | Investigations | 27.1 | Non-systematic Assessment |
|
| New onset diabetes after transplantation | Investigations | 27.1 | Non-systematic Assessment |
|
| Obesity | Investigations | 27.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 27.1 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | 27.1 | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | 27.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | 27.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | 27.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | 27.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | 27.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | 27.1 | Non-systematic Assessment |
|
| Intention tremor | Nervous system disorders | 27.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | 27.1 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | 27.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | 27.1 | Non-systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | 27.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | 27.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | 27.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | 27.1 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | 27.1 | Non-systematic Assessment |
|
| Stress | Psychiatric disorders | 27.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Perinephric collection | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | 27.1 | Non-systematic Assessment |
|
| Penile haematoma | Reproductive system and breast disorders | 27.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.1 | Non-systematic Assessment |
|
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | 27.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 27.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 27.1 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | 27.1 | Non-systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | 27.1 | Non-systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | 27.1 | Non-systematic Assessment |
|
| Dermatosis | Skin and subcutaneous tissue disorders | 27.1 | Non-systematic Assessment |
|
| Diffuse alopecia | Skin and subcutaneous tissue disorders | 27.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | 27.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 27.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 27.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | 27.1 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | 27.1 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | 27.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | 27.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | 27.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | 27.1 | Non-systematic Assessment |
|
| Poor peripheral circulation | Vascular disorders | 27.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
| Positive |
|
|
|
|
|
| Polycystic disease |
|
| Hypertension/nephrosclerosis |
|
| Diabetes Mellitus |
|
| IgA nephropathy |
|
| Pyelonephritis |
|
| Drug Induced Toxicity |
|
| Interstitial Nephritis |
|
| Vasculitis |
|
| Renal Hypoplasia/Dysplasia |
|
| Other |
|
| Unknown |
|
| Peritoneal Dialysis |
|
| None |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Month 12 |
|
|