Trial Outcomes & Findings for Belatacept to Prevent Organ Rejection in Kidney Transplant Patients (NCT NCT00346151)
NCT ID: NCT00346151
Last Updated: 2017-04-21
Results Overview
Cumulative incidence of acute rejection\[1\] at 6 months post-transplant based on local pathology biopsy reads 1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater\[2\] 2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
TERMINATED
PHASE2
5 participants
6 months post-transplant
2017-04-21
Participant Flow
Two centers in the United States enrolled five recipients of non-human leukocyte antigen (HLA)-identical living-donor-related renal transplants between January 2007 and January 2009.
At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and sign the informed consent form.
Participant milestones
| Measure |
Belatacept
Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Belatacept
Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-transplantPopulation: Intent to Treat
Cumulative incidence of acute rejection\[1\] at 6 months post-transplant based on local pathology biopsy reads 1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater\[2\] 2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Acute Rejection at 6-Months
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 months post-transplantPopulation: Intent to Treat Sample participants not terminating prior to 12 months.
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=4 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Participant Survival at 12 Months Post-Transplant
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 months post-transplantPopulation: Intent to Treat Sample
Incidence of acute rejection\[1\] at 12 months post-transplant 1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater\[2\] 2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Acute Rejection at 12-Months
|
4 Participants
|
SECONDARY outcome
Timeframe: 48 monthsPopulation: Intent to treat sample that initiated sirolimus withdrawal
Time from transplantation to initiation of sirolimus withdrawal.
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=1 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Tolerance Induction
|
391 Days
|
SECONDARY outcome
Timeframe: 24 weeks post-transplantPopulation: Intent to Treat Sample
GFR utilizing clearance of iothalamate. GFR is an index of level of kidney function. A higher value means better kidney function.
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=3 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
|
62.0 mL/min/1.73m^2
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 12 months post-transplantPopulation: Intent to treat sample participants not terminating prior to 12 months
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=4 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Graft Survival at 12 Months Post-transplant
|
4 Participants
|
SECONDARY outcome
Timeframe: Transplantation until rejection occurs (participants followed up to four years post-transplantation)Population: Intent to treat sample participants with rejection
Time (days) from transplant to occurrence of acute rejection\[1\] 1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater\[2\] 2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=4 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Time From Transplant to Acute Rejection
|
15 Days
Full Range 95.4 • Interval 1.0 to 200.0
|
SECONDARY outcome
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)Population: Intent to Treat Sample
Proportion of participants who experienced acute rejection\[1\] requiring antilymphocyte therapy 1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater\[2\] 2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection
|
0 Participants
|
SECONDARY outcome
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)Population: Intent to Treat Sample
Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Proportion of Participants With Post-transplant Infections
|
4 Participants
|
SECONDARY outcome
Timeframe: Start of study to end of studyPopulation: Intent to Treat Sample
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Proportion of Participants With Wound Complications
|
0 Participants
|
SECONDARY outcome
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)Population: Intent to Treat Sample
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Proportion of Participants With Malignancies
|
0 Participants
|
SECONDARY outcome
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)Population: Intent to Treat Sample
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Proportion of Participants With a Sirolimus Associated Adverse Event
|
5 Participants
|
SECONDARY outcome
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)Population: Intent to Treat Sample
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Proportion of Participants With Chronic Allograft Nephropathy
|
0 Participants
|
SECONDARY outcome
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)Population: Intent to Treat Sample
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Proportion of Participants With Delayed Graft Function
|
0 Participants
|
SECONDARY outcome
Timeframe: Participants followed from transplantation until completion of study (up to four years post-transplantation)Population: Intent to Treat Sample
Outcome measures
| Measure |
Immunosuppression Withdrawal
n=5 Participants
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Proportion of Participants With Post-transplant Diabetes Mellitus
|
1 Participants
|
Adverse Events
Immunosuppression Withdrawal
Serious adverse events
| Measure |
Immunosuppression Withdrawal
n=5 participants at risk
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Blood and lymphatic system disorders
Lymphocele
|
20.0%
1/5 • Number of events 1
|
|
Immune system disorders
Kidney transplant rejection
|
80.0%
4/5 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Immunosuppression Withdrawal
n=5 participants at risk
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
3/5 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukopenia
|
40.0%
2/5 • Number of events 3
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
20.0%
1/5 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • Number of events 1
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
20.0%
1/5 • Number of events 1
|
|
Endocrine disorders
Hyperparathyroidism
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Vision blurred
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
1/5 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
80.0%
4/5 • Number of events 4
|
|
Gastrointestinal disorders
Mouth ulceration
|
40.0%
2/5 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Asthenia
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 4
|
|
General disorders
Malaise
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Oedema
|
60.0%
3/5 • Number of events 4
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Pyrexia
|
40.0%
2/5 • Number of events 2
|
|
Infections and infestations
BK virus infection
|
40.0%
2/5 • Number of events 2
|
|
Infections and infestations
Cytomegalovirus viraemia
|
20.0%
1/5 • Number of events 3
|
|
Infections and infestations
Diverticulitis
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Epstein-Barr viraemia
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Folliculitis
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Herpes virus infection
|
20.0%
1/5 • Number of events 4
|
|
Infections and infestations
Oral infection
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
40.0%
2/5 • Number of events 3
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
20.0%
1/5 • Number of events 1
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
20.0%
1/5 • Number of events 2
|
|
Injury, poisoning and procedural complications
Incision site pain
|
40.0%
2/5 • Number of events 2
|
|
Injury, poisoning and procedural complications
Medical device pain
|
20.0%
1/5 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
20.0%
1/5 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Weight increased
|
40.0%
2/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Acidosis
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
60.0%
3/5 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
40.0%
2/5 • Number of events 2
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 2
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 2
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
20.0%
1/5 • Number of events 1
|
|
Renal and urinary disorders
Renal disorder
|
20.0%
1/5 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
20.0%
1/5 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal oedema
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
40.0%
2/5 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
1/5 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
40.0%
2/5 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1
|
|
Vascular disorders
Hypertension
|
40.0%
2/5 • Number of events 2
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place