An observational study in Kidney Transplantation, sponsored by Hoffmann-La Roche. Completed at 2 sites in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-11.
Sponsored by Hoffmann-La Roche · Observational
This observational study will evaluate renal function in participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months following transplantation.
The participant sampling method used in the Orange study was consecutive sampling, a non-probability sampling method where each participant meeting the study's inclusion and exclusion criteria is selected and enrolled in the study until the pre-set sample size is achieved.
Thus, in the Orange study de novo kidney transplanted participants, who were on mycophenolate mofetil immunosuppressive combination therapy in routine clinical practice, were selected in a consecutive manner (a non-probability sampling method) if they met the inclusion/exclusion criteria until 128 participants were recruited to the study.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Renal allograft transplant participants initiated on combined immunosuppressive treatment containing mycophenolate mofetil
Exclusion Criteria:
Renal transplant participants who will be subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, will be followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurs first. The choice of treatment will be made prior to enrolment by the treating physician. The treatment will be administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC).
Drug: Mycophenolate Mofetil · Drug: Immunosuppressive Therapy
Protocol does not specify any regimen for treatment. The choice of treatment will be made prior to enrollment by the treating physician.
Also known as: CellCept
Protocol does not specify any particular immunosuppressive drug and regimen for treatment. The choice of immunosuppressive therapy will be made prior to enrollment by the treating physician.
Creatinine Clearance at 1 Month After Transplantation
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time frame: Month 1
Creatinine Clearance at Month 6 After Transplantation
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time frame: Month 6
Creatinine Clearance at Month 12 After Transplantation
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time frame: Month 12
Glomerular Filtration Rate (GFR) at Month 1 After Transplantation
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (\>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (\<) 15 mL/min indicates kidney failure.
Time frame: Month 1
GFR at Month 6 After Transplantation
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \< 15 mL/min indicates kidney failure.
Time frame: Month 6
GFR at Month 12 After Transplantation
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \< 15 mL/min indicates kidney failure.
Time frame: Month 12
Mean Dose of Mycophenolate Mofetil
Time frame: Baseline, Months 1, 6, and 12
Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil
Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.
Time frame: Baseline, Months 1, 6, and 12
Percentage of Participants With Acute Rejection
Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.
Time frame: Baseline to Month 1, Months 2 to 6, Months 7 to 12
Percentage of Participants With Graft Survival
Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \>8 weeks), re-transplant or death during the first 12 months after transplantation.
Time frame: Months 1, 6, and 12
| Milestone | Renal Transplant Participants |
|---|---|
| Started | 128 |
| Intent-to-treat (itt) population | 123 |
| Completed | 73 |
| Not completed | 55 |
| Withdrew: Protocol violation | 48 |
| Withdrew: Death | 2 |
| Withdrew: Icf signed after transplantation | 5 |
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
| mL/min | Renal Transplant Participants |
|---|---|
| Creatinine Clearance at 1 Month After Transplantation | 65.82 ± 18.32 |
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
| mL/min | Renal Transplant Participants |
|---|---|
| Creatinine Clearance at Month 6 After Transplantation | 73.38 ± 19.43 |
Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
| mL/min | Renal Transplant Participants |
|---|---|
| Creatinine Clearance at Month 12 After Transplantation | 69.69 ± 21.05 |
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (\>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (\<) 15 mL/min indicates kidney failure.
| mL/min | Renal Transplant Participants |
|---|---|
| Glomerular Filtration Rate (GFR) at Month 1 After Transplantation | 53.54 ± 33.43 |
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \< 15 mL/min indicates kidney failure.
| mL/min | Renal Transplant Participants |
|---|---|
| GFR at Month 6 After Transplantation | 56.78 ± 15.36 |
GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \< 15 mL/min indicates kidney failure.
| mL/min | Renal Transplant Participants |
|---|---|
| GFR at Month 12 After Transplantation | 58.03 ± 16.29 |
| milligrams (mg) | Renal Transplant Participants |
|---|---|
| Baseline (n=121) | 2033.06 ± 357.86 |
| Month 1 (n=119) | 1718.49 ± 543.21 |
| Month 6 (n=88) | 1457.39 ± 754.51 |
| Month 12 (n=69) | 1539.86 ± 669.21 |
Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.
| percentage of participants | Renal Transplant Participants |
|---|---|
| 1 Other agent: at baseline (n=121) | 0.8 |
| 1 Other agent: at Month 1 (n=119) | 0.8 |
| 1 Other agent: at Month 6 (n=86) | 2.3 |
| 1 Other agent: at Month 12 (n=69) | 7.2 |
| 2 Other agents: at baseline (n=121) | 90.9 |
| 2 Other agents: at Month 1 (n=119) | 99.2 |
| 2 Other agents: at Month 6 (n=86) | 97.7 |
| 2 Other agents: at Month 12 (n=69) | 92.8 |
| 3 Other agents: at baseline (n=121) | 8.3 |
| 3 Other agents: at Month 1 (n=119) | 0 |
| 3 Other agents: at Month 6 (n=86) | 0 |
| 3 Other agents: at Month 12 (n=69) | 0 |
Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.
| percentage of participants | Renal Transplant Participants |
|---|---|
| Baseline to Month 1 (n=127) | 16.5 |
| Months 2 to 6 (n=124) | 0.8 |
| Months 7 to 12 (n=111) | 0.9 |
Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for \>8 weeks), re-transplant or death during the first 12 months after transplantation.
| percentage of participants | Renal Transplant Participants |
|---|---|
| Month 1 (n=127) | 100 |
| Month 6 (n=123) | 99.2 |
| Month 12 (n=111) | 98.4 |
Collected over From Baseline up to Month 12. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Renal Transplant Participants | — | 33/128 (25.8%) | 51/128 (39.8%) |
| Event | Renal Transplant Participants |
|---|---|
| Transplant rejectionImmune system disorders | 14/128 |
| Kidney transplant rejectionImmune system disorders | 4/128 |
| PneumoniaInfections and infestations | 3/128 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 2/128 |
| Ureteric anastomosis complicationInjury, poisoning and procedural complications | 2/128 |
| PyelocaliectasisRenal and urinary disorders | 2/128 |
| HaematomaVascular disorders | 2/128 |
| Acute myocardial infarctionCardiac disorders | 1/128 |
| DiarrhoeaGastrointestinal disorders | 1/128 |
| Sudden deathGeneral disorders | 1/128 |
| Event | Renal Transplant Participants |
|---|---|
| Urinary tract infectionRenal and urinary disorders | 24/128 |
| DiarrhoeaGastrointestinal disorders | 19/128 |
| AnemiaBlood and lymphatic system disorders | 13/128 |
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 10/128 |
| HyperuricaemiaRenal and urinary disorders | 7/128 |
ITT population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy and had no major protocol violation.
| Age, Continuous(years) | Renal Transplant Participants |
|---|---|
| Mean | 49.60 ± 13.24 |
| Sex: Female, Male(Participants) | Renal Transplant Participants |
|---|---|
| Female | 44 |
| Male | 79 |
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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