Anemia, Kidney Transplantation
Conditions
Brief summary
This observational study will investigate efficacy and safety of methoxy polyethyleneglycol-epoetin beta in participants with a kidney transplant. Data of each participant will be collected over 15 months of Mircera therapy.
Interventions
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with kidney transplant and a chronic kidney disease (CKD), who need erythropoiesis stimulating agent (ESA) therapy as part of their medical care and prescribed methoxy polyethyleneglycol-epoetin beta by the doctor. * The transplant should function regularly and without need of continuous dialysis treatment at inclusion and also during the documentation period of this study according to treating physician's prognosis.
Exclusion criteria
* Kidney transplantation dates back less than 3 months. Acute decrease of hemoglobin (Hb) before enrollment, defined as decrease of greater than or equal to (\>/=) 2 g/dL between two sequential values. * Administration of other ESA therapies during the observation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment | Up to 50 months |
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) | From Month 7 to Month 9 |
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | From Month 7 to Month 12 |
| Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | From Month 7 to Month 15 |
| Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | From Month 7 to Month 12 |
| Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | From Month 7 to Month 15 |
| Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) | From Month 7 to Month 9 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Level Based on the Presence of Inflammatory Diseases | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases. |
| Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease. |
| Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes. |
| Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance \[milliliters per minute (mL/min)\] = \[(140 minus age) multiplied by (\*) (body weight in kilogram \[kg\]) divided by \[72 \* serum creatinine milligrams per deciliter (mg/dL)\]. For females, creatinine clearance (mL/min) = 0.85 \* \[(140 minus age) \* (body weight in kg)\] divided by \[72 \* serum creatinine (mg/dL)\]. Participants were classified based on the GFR in to two groups; GFR less than (\<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented. |
| Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15) | Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kidney Transplant Participants Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months. | 279 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administration of other ESA | 11 |
| Overall Study | Administrative reason | 5 |
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 4 |
| Overall Study | Did not receive any Mircera dose | 11 |
| Overall Study | Missing | 5 |
| Overall Study | Necessity of dialysis | 20 |
| Overall Study | No further treatment necessary | 18 |
| Overall Study | Not recorded | 7 |
| Overall Study | Other | 7 |
| Overall Study | Surgery | 1 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Kidney Transplant Participants |
|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 14.07 |
| Sex: Female, Male Female | 137 Participants |
| Sex: Female, Male Male | 142 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 279 |
| serious Total, serious adverse events | 32 / 279 |
Outcome results
Primary
Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment
Time frame: Up to 50 months
Population: Efficacy analysis set. Participants with non-missing values were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kidney Transplant Participants | Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment | 9.31 months | Standard Deviation 6.25 |
Primary
Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)
Time frame: From Month 7 to Month 12
Population: Efficacy analysis set. Participants who were evaluable at the specified time frame were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kidney Transplant Participants | Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | 52.6 percentage of participants |
Primary
Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)
Time frame: From Month 7 to Month 15
Population: Efficacy analysis set. Participants who were evaluable at the specified time frame were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kidney Transplant Participants | Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | 41.2 percentage of participants |
Primary
Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)
Time frame: From Month 7 to Month 9
Population: Efficacy analysis set (Included participants who reported no pregnancy during the study period and had dosing and hemoglobin data available during 1 of the 3 visits \[Visits 7-9\]).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kidney Transplant Participants | Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9) | 20.7 percentage of participants |
Primary
Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)
Time frame: From Month 7 to Month 12
Population: Efficacy analysis set. Participants who were evaluable at the specified time frame were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kidney Transplant Participants | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12) | 21.2 percentage of participants |
Primary
Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)
Time frame: From Month 7 to Month 15
Population: Efficacy analysis set. Participants who were evaluable at the specified time frame were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kidney Transplant Participants | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15) | 12.2 percentage of participants |
Primary
Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)
Time frame: From Month 7 to Month 9
Population: Efficacy analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kidney Transplant Participants | Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9) | 40.4 percentage of participants |
Secondary
Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study
Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)
Population: Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 3 (Month 3) (n=155, 0) | 11.65 g/dL | Standard Deviation 1.24 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 4 (Month 4) (n=150, 0) | 11.51 g/dL | Standard Deviation 1.229 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 1 (Month 1) (n=135, 0) | 11.23 g/dL | Standard Deviation 1.143 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 2 (Month 2) (n=142, 0) | 11.40 g/dL | Standard Deviation 1.231 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 5 (Month 5) (n=147, 0) | 11.75 g/dL | Standard Deviation 1.13 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 6 (Month 6) (n=132, 0) | 11.57 g/dL | Standard Deviation 1.159 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 7 (Month 7) (n=141, 0) | 11.53 g/dL | Standard Deviation 1.139 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 8 (Month 8) (n=137, 0) | 11.50 g/dL | Standard Deviation 1.254 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 9 (Month 9) (n=141, 0) | 11.57 g/dL | Standard Deviation 1.294 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 10 (Month 10) (n=128, 0) | 11.53 g/dL | Standard Deviation 1.224 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 11 (Month 11) (n=116, 0) | 11.59 g/dL | Standard Deviation 1.231 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 12 (Month 12) (n=132, 0) | 11.37 g/dL | Standard Deviation 1.21 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 13 (Month 13) (n=122, 0) | 11.24 g/dL | Standard Deviation 1.285 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 14 (Month 14) (n=118, 0) | 11.32 g/dL | Standard Deviation 1.035 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Visit 15 (Month 15) (n=104, 0) | 11.40 g/dL | Standard Deviation 1.101 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study | Entire study (Month 1 to Month 15) (n=192, 0) | 11.45 g/dL | Standard Deviation 0.839 |
Secondary
Hemoglobin Level Based on the Etiology of Chronic Kidney Disease
Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)
Population: Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 5 (Month 5) (n=46, 40) | 11.88 g/dL | Standard Deviation 1.156 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 1 (Month 1) (n=43, 37) | 11.27 g/dL | Standard Deviation 1.254 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 2 (Month 2) (n=43, 40) | 11.42 g/dL | Standard Deviation 1.24 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 3 (Month 3) (n=49, 46) | 11.79 g/dL | Standard Deviation 1.298 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 4 (Month 4) (n=49, 41) | 11.37 g/dL | Standard Deviation 1.27 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 6 (Month 6) (n=40, 36) | 11.62 g/dL | Standard Deviation 1.129 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 7 (Month 7) (n=46, 44) | 11.71 g/dL | Standard Deviation 1.27 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 8 (Month 8) (n=39, 35) | 11.71 g/dL | Standard Deviation 1.305 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 9 (Month 9) (n=45, 40) | 11.88 g/dL | Standard Deviation 1.126 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 10 (Month 10) (n=44, 31) | 11.60 g/dL | Standard Deviation 1.266 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 11 (Month 11) (n=33, 38) | 11.96 g/dL | Standard Deviation 1.236 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 12 (Month 12) (n=36, 41) | 11.33 g/dL | Standard Deviation 1.452 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 13 (Month 13) (n=41, 36) | 11.32 g/dL | Standard Deviation 1.53 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 14 (Month 14) (n=40, 33) | 11.59 g/dL | Standard Deviation 1.077 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 15 (Month 15) (n=35, 31) | 11.40 g/dL | Standard Deviation 1.296 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Entire study (Month 1 to Month 15) (n=60, 55) | 11.52 g/dL | Standard Deviation 0.924 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Entire study (Month 1 to Month 15) (n=60, 55) | 11.52 g/dL | Standard Deviation 0.876 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 9 (Month 9) (n=45, 40) | 11.46 g/dL | Standard Deviation 1.594 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 1 (Month 1) (n=43, 37) | 11.44 g/dL | Standard Deviation 1.149 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 13 (Month 13) (n=41, 36) | 11.20 g/dL | Standard Deviation 1.208 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 2 (Month 2) (n=43, 40) | 11.48 g/dL | Standard Deviation 1.33 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 10 (Month 10) (n=44, 31) | 11.67 g/dL | Standard Deviation 1.323 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 3 (Month 3) (n=49, 46) | 11.75 g/dL | Standard Deviation 1.266 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 15 (Month 15) (n=35, 31) | 11.47 g/dL | Standard Deviation 1.14 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 4 (Month 4) (n=49, 41) | 11.76 g/dL | Standard Deviation 1.172 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 5 (Month 5) (n=46, 40) | 11.72 g/dL | Standard Deviation 1.172 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 11 (Month 11) (n=33, 38) | 11.47 g/dL | Standard Deviation 1.327 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 6 (Month 6) (n=40, 36) | 11.68 g/dL | Standard Deviation 1.197 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 14 (Month 14) (n=40, 33) | 11.26 g/dL | Standard Deviation 1.1 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 7 (Month 7) (n=46, 44) | 11.52 g/dL | Standard Deviation 1.227 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 12 (Month 12) (n=36, 41) | 11.37 g/dL | Standard Deviation 1.196 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Etiology of Chronic Kidney Disease | Visit 8 (Month 8) (n=39, 35) | 11.60 g/dL | Standard Deviation 1.439 |
Secondary
Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)
GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance \[milliliters per minute (mL/min)\] = \[(140 minus age) multiplied by (\*) (body weight in kilogram \[kg\]) divided by \[72 \* serum creatinine milligrams per deciliter (mg/dL)\]. For females, creatinine clearance (mL/min) = 0.85 \* \[(140 minus age) \* (body weight in kg)\] divided by \[72 \* serum creatinine (mg/dL)\]. Participants were classified based on the GFR in to two groups; GFR less than (\<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)
Population: Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 11 (Month 11) (n=30, 38) | 11.55 g/dL | Standard Deviation 1.071 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 6 (Month 6) (n=34, 41) | 11.32 g/dL | Standard Deviation 1.158 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 2 (Month 2) (n=35, 45) | 11.17 g/dL | Standard Deviation 1.234 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 7 (Month 7) (n=36, 46) | 11.46 g/dL | Standard Deviation 1.108 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 3 (Month 3) (n=40, 48) | 11.60 g/dL | Standard Deviation 1.205 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 8 (Month 8) (n=28, 48) | 11.46 g/dL | Standard Deviation 1.215 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 15 (Month 15) (n=24, 35) | 11.20 g/dL | Standard Deviation 1.093 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 9 (Month 9) (n=38, 46) | 11.50 g/dL | Standard Deviation 1.369 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 4 (Month 4) (n=37, 52) | 11.26 g/dL | Standard Deviation 1.242 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 10 (Month 10) (n=30, 41) | 11.22 g/dL | Standard Deviation 1.063 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 1 (Month 1) (n=35, 41) | 11.15 g/dL | Standard Deviation 0.952 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 12 (Month 12) (n=27, 45) | 11.41 g/dL | Standard Deviation 0.943 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 5 (Month 5) (n=37, 47) | 11.40 g/dL | Standard Deviation 1.09 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 13 (Month 13) (n=31, 39) | 11.44 g/dL | Standard Deviation 1.048 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 14 (Month 14) (n=27, 41) | 11.29 g/dL | Standard Deviation 1.056 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Entire study (Month 1 to Month 15) (n=46, 60) | 11.26 g/dL | Standard Deviation 0.784 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 14 (Month 14) (n=27, 41) | 11.40 g/dL | Standard Deviation 1.089 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 11 (Month 11) (n=30, 38) | 11.69 g/dL | Standard Deviation 1.126 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 13 (Month 13) (n=31, 39) | 11.41 g/dL | Standard Deviation 1.363 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 15 (Month 15) (n=24, 35) | 11.81 g/dL | Standard Deviation 0.993 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Entire study (Month 1 to Month 15) (n=46, 60) | 11.62 g/dL | Standard Deviation 0.716 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 1 (Month 1) (n=35, 41) | 11.44 g/dL | Standard Deviation 1.2 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 3 (Month 3) (n=40, 48) | 11.65 g/dL | Standard Deviation 0.954 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 4 (Month 4) (n=37, 52) | 11.75 g/dL | Standard Deviation 1.086 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 5 (Month 5) (n=37, 47) | 11.87 g/dL | Standard Deviation 1.104 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 6 (Month 6) (n=34, 41) | 11.90 g/dL | Standard Deviation 1.257 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 7 (Month 7) (n=36, 46) | 11.62 g/dL | Standard Deviation 1.223 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 8 (Month 8) (n=28, 48) | 11.66 g/dL | Standard Deviation 1.165 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 9 (Month 9) (n=38, 46) | 11.85 g/dL | Standard Deviation 1.161 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 10 (Month 10) (n=30, 41) | 11.88 g/dL | Standard Deviation 0.992 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 12 (Month 12) (n=27, 45) | 11.67 g/dL | Standard Deviation 1.038 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Glomerular Filtration Rate (GFR) | Visit 2 (Month 2) (n=35, 45) | 11.42 g/dL | Standard Deviation 1.103 |
Secondary
Hemoglobin Level Based on the Presence of Inflammatory Diseases
Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)
Population: Efficacy analysis set. n = number of participants who were evaluable at a particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 1 (Month 1) (n=41, 94) | 11.30 g/dL | Standard Deviation 1.168 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 2 (Month 2) (n=43, 100) | 11.33 g/dL | Standard Deviation 1.231 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 3 (Month 3) (n=45, 110) | 11.75 g/dL | Standard Deviation 1.419 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 4 (Month 4) (n=47, 104) | 11.54 g/dL | Standard Deviation 1.209 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 5 (Month 5) (n=43, 104) | 11.71 g/dL | Standard Deviation 1.135 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 6 (Month 6) (n=42, 91) | 11.34 g/dL | Standard Deviation 1.068 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 7 (Month 7) (n=40, 102) | 11.46 g/dL | Standard Deviation 1.276 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 8 (Month 8) (n=40, 97) | 11.58 g/dL | Standard Deviation 1.324 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 9 (Month 9) (n=42, 100) | 11.61 g/dL | Standard Deviation 1.236 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 10 (Month 10) (n=34, 94) | 11.63 g/dL | Standard Deviation 0.996 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 11 (Month 11) (n=34, 83) | 11.75 g/dL | Standard Deviation 1.015 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 12 (Month 12) (n=33, 99) | 11.23 g/dL | Standard Deviation 1.095 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 13 (Month 13) (n=36, 87) | 11.17 g/dL | Standard Deviation 1.129 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 14 (Month 14) (n=31, 88) | 11.07 g/dL | Standard Deviation 1.09 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 15 (Month 15) (n=27, 78) | 11.03 g/dL | Standard Deviation 1.157 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Entire study (Month 1 to Month 15) (n=56, 137) | 11.38 g/dL | Standard Deviation 0.73 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Entire study (Month 1 to Month 15) (n=56, 137) | 11.48 g/dL | Standard Deviation 0.878 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 1 (Month 1) (n=41, 94) | 11.20 g/dL | Standard Deviation 1.137 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 9 (Month 9) (n=42, 100) | 11.55 g/dL | Standard Deviation 1.318 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 2 (Month 2) (n=43, 100) | 11.44 g/dL | Standard Deviation 1.236 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 13 (Month 13) (n=36, 87) | 11.26 g/dL | Standard Deviation 1.346 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 3 (Month 3) (n=45, 110) | 11.61 g/dL | Standard Deviation 1.163 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 10 (Month 10) (n=34, 94) | 11.50 g/dL | Standard Deviation 1.3 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 4 (Month 4) (n=47, 104) | 11.51 g/dL | Standard Deviation 1.24 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 15 (Month 15) (n=27, 78) | 11.55 g/dL | Standard Deviation 1.056 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 5 (Month 5) (n=43, 104) | 11.76 g/dL | Standard Deviation 1.133 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 11 (Month 11) (n=34, 83) | 11.53 g/dL | Standard Deviation 1.302 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 6 (Month 6) (n=42, 91) | 11.68 g/dL | Standard Deviation 1.184 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 14 (Month 14) (n=31, 88) | 11.42 g/dL | Standard Deviation 1.003 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 7 (Month 7) (n=40, 102) | 11.56 g/dL | Standard Deviation 1.08 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 12 (Month 12) (n=33, 99) | 11.41 g/dL | Standard Deviation 1.248 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Presence of Inflammatory Diseases | Visit 8 (Month 8) (n=40, 97) | 11.46 g/dL | Standard Deviation 1.23 |
Secondary
Hemoglobin Level Based on the Type of Kidney Transplantation Performed
Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation.
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)
Population: Efficacy analysis set. n = number of participants who were evaluable at a particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 9 (Month 9) (n=17, 125) | 11.36 g/dL | Standard Deviation 1.386 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 4 (Month 4) (n=23, 128) | 11.30 g/dL | Standard Deviation 1.213 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 10 (Month 10) (n=21, 107) | 11.26 g/dL | Standard Deviation 1.435 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 2 (Month 2) (n=25, 118) | 11.37 g/dL | Standard Deviation 1.215 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 11 (Month 11) (n=18, 99) | 11.46 g/dL | Standard Deviation 1.079 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 5 (Month 5) (n=25, 122) | 11.74 g/dL | Standard Deviation 1.174 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 12 (Month 12) (n=22, 110) | 11.12 g/dL | Standard Deviation 1.437 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 1 (Month 1) (n=22, 113) | 11.08 g/dL | Standard Deviation 1.244 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 13 (Month 13) (n=23, 100) | 10.86 g/dL | Standard Deviation 1.386 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 6 (Month 6) (n=20, 113) | 11.08 g/dL | Standard Deviation 0.896 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 14 (Month 14) (n=18, 101) | 11.21 g/dL | Standard Deviation 1.018 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 3 (Month 3) (n=27, 128) | 11.34 g/dL | Standard Deviation 1.163 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 15 (Month 15) (n=21, 84) | 11.05 g/dL | Standard Deviation 1.187 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 7 (Month 7) (n=21, 121) | 11.23 g/dL | Standard Deviation 1.132 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Entire study (Month 1 to Month 15) (n=34, 159) | 11.25 g/dL | Standard Deviation 0.853 |
| Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 8 (Month 8) (n=24, 113) | 11.18 g/dL | Standard Deviation 1.305 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Entire study (Month 1 to Month 15) (n=34, 159) | 11.49 g/dL | Standard Deviation 0.83 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 1 (Month 1) (n=22, 113) | 11.26 g/dL | Standard Deviation 1.126 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 2 (Month 2) (n=25, 118) | 11.41 g/dL | Standard Deviation 1.239 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 3 (Month 3) (n=27, 128) | 11.71 g/dL | Standard Deviation 1.25 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 4 (Month 4) (n=23, 128) | 11.56 g/dL | Standard Deviation 1.229 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 5 (Month 5) (n=25, 122) | 11.75 g/dL | Standard Deviation 1.126 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 6 (Month 6) (n=20, 113) | 11.66 g/dL | Standard Deviation 1.177 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 8 (Month 8) (n=24, 113) | 11.57 g/dL | Standard Deviation 1.239 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 9 (Month 9) (n=17, 125) | 11.60 g/dL | Standard Deviation 1.28 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 10 (Month 10) (n=21, 107) | 11.59 g/dL | Standard Deviation 1.179 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 11 (Month 11) (n=18, 99) | 11.62 g/dL | Standard Deviation 1.254 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 12 (Month 12) (n=22, 110) | 11.41 g/dL | Standard Deviation 1.161 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 13 (Month 13) (n=23, 100) | 11.32 g/dL | Standard Deviation 1.248 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 14 (Month 14) (n=18, 101) | 11.35 g/dL | Standard Deviation 1.039 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 15 (Month 15) (n=21, 84) | 11.50 g/dL | Standard Deviation 1.067 |
| Cadaveric Donation-Kidney Transplant Participants | Hemoglobin Level Based on the Type of Kidney Transplantation Performed | Visit 7 (Month 7) (n=21, 121) | 11.59 g/dL | Standard Deviation 1.132 |