Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients
Study Details
Study Description
Brief Summary
Alemtuzumab is a man-made antibody used to treat certain blood disorders. This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor. The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
Organ transplantation is a common procedure in hospitals, but organ rejection and serious side effects are potential problems for the patient. Mycophenolate mofetil, sirolimus, and tacrolimus are drugs used to decrease immune system activity in people who have received organ transplants so that the new organ will not be rejected. Alemtuzumab is a monoclonal antibody that binds to and depletes excess T cells in the bone marrow of leukemia patients. In this study, alemtuzumab will be used to destroy the recipient's white blood cells (WBCs) at the time of transplantation. It is hoped that WBCs produced after alemtuzumab administration will recognize the transplanted liver as "self" and will not attack the new kidney.
To further assist the immune system in accepting the donor kidney, some patients in this study will also receive two infusions of bone marrow stem cells from the kidney donor. Bone marrow stem cells are adult blood cells from which other specialized blood cells, such as T cells, develop. Treatment with these cells is believed to create a state of "chimerism" in the body, where the immune cells of both the donor and recipient can coexist and tolerate the presence of a donor organ. This study will evaluate the safety and effectiveness of an antirejection regimen including alemtuzumab and other immunosuppressive medications and donor bone marrow stem cell infusions in patients undergoing kidney transplantation.
This study will last 3 years. Participants will be randomly assigned to receive either the full immunosuppressive therapy and donor bone marrow stem cell infusions (Group 1) or immunosuppressive therapy alone (Group 2). Patients will undergo kidney transplantation at the start of the study on Day 0. Patients will receive inpatient infusions of alemtuzumab on Days 0 and 4. Starting on Day 0, patients will begin taking mycophenolate mofetil; starting on Day 1, patients will also begin taking tacrolimus. On Day 5, patients in Group 1 will receive their first of 2 infusions of purified stem cells taken from the kidney donor's bone marrow; their second infusion of stem cells will occur sometime between Months 4 and 6 post-transplant.
Beginning between Months 4 and 6 post-transplant, all participants will begin receiving low-dose maintenance immunosuppressive therapy with sirolimus, as is typical for post-transplant antirejection therapy. One year post-transplant, patients will be evaluated for the potential to withdraw some or all of this maintenance immunotherapy. Participants will be monitored for 3 years post-transplant. Urine collection will occur at Week 1 and Months 1, 3, 6, and 9. At Months 12, 24, and 30, participants will undergo kidney biopsies. Blood collection will occur at regular intervals for laboratory tests to evaluate the immune system's response to the transplanted kidney.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DBMCs Kidney transplantation, followed by immunotherapy given along with kidney donor Donor bone Bone marrow Marrow stem cell Cells (DBMCs) infusions |
Drug: Alemtuzumab
Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4
Other Names:
Drug: Mycophenolate mofetil
Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study
Other Names:
Drug: Sirolimus
Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or end of the study
Other Names:
Drug: Tacrolimus
Immunosuppressant; daily dose starting Day 1 until withdrawal or end of the study
Other Names:
Procedure: Donor bone marrow stem cell infusion
2 doses of kidney donor's bone marrow stem cells by IV infusion on Day 5 and sometime between Months 4 and 6
Procedure: Kidney transplant
Occurs at study entry
|
| Active Comparator: Control Group Kidney transplantation, followed by immunotherapy |
Drug: Alemtuzumab
Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4
Other Names:
Drug: Mycophenolate mofetil
Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study
Other Names:
Drug: Sirolimus
Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or end of the study
Other Names:
Drug: Tacrolimus
Immunosuppressant; daily dose starting Day 1 until withdrawal or end of the study
Other Names:
Procedure: Kidney transplant
Occurs at study entry
|
Outcome Measures
Primary Outcome Measures
- Overall Participant Survival at One Year Post Kidney Transplant [One year post kidney transplant]
- Overall Kidney Graft Survival at One Year Post-Transplant [One year post kidney transplant]
Number of participants that did not experience kidney graft failure[1] at one year post-transplant [1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation.
Secondary Outcome Measures
- Participant Survival at Three Years Post Kidney Transplant [Three years post kidney transplant]
- Graft Survival at Three Years Post-Transplant [Three years post kidney transplant]
Number of participants that did not experience kidney graft failure[1] at three years post-transplant [1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation.
- Number of Kidney Biopsy-proven Acute Rejection [Three years post kidney transplant]
Biopsy-proven acute renal (kidney) rejection[1,2]. Diagnosis of acute rejection was made by renal 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, with higher scores indicating more severe rejection[2] Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999
- Number of Chronic Allograft Nephropathies [Three years post kidney transplant]
Number of chronic allograft nephropathies[1,2,3] at 3 years post kidney transplant. Chronic allograft nephropathy is defined as renal biopsies with Banff 97 Grade I or greater[2] with higher numeric scores indicating more severe nephropathy The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification[3] Reference: Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999
- Number of Graft-versus-host Disease (GVHD) Events [Three years post kidney transplant]
A disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. Also called graft-versus-host disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Weight greater than 40 kg (88.2 lbs)
-
Will be receiving a living-related (1-haplotype-matched donor/recipient) primary kidney allograft
-
Negative B-cell and T-cell cytotoxic and flow cytometry crossmatch (1-haplotype-matched donor/recipient pairs with a minimum of 1 HLA DR 1A and 1B locus in common and panel-reactive antibodies [PRA] of less than 10%)
-
Normal echocardiogram (ECG) with an ejection fraction of greater than 50%
-
Received full course of vaccination for hepatitis B virus (HBV), completed at least 6 weeks before transplantation, OR has naturally acquired immunity
-
Willing to comply with the study visits
-
Willing to use acceptable forms of contraception
Exclusion Criteria:
-
Previously received or is receiving an organ transplant other than a kidney
-
Receiving an ABO (blood type) incompatible donor kidney
-
Human Immunodeficiency Virus (HIV) infected
-
Antibody positive for hepatitis C virus (HCV)
-
Surface antigen positive for hepatitis B virus (HBV)
-
Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB (positive Mantoux test)
-
Current cancer or a history of cancer within the 5 years prior to study entry. Patients who have had successfully treated nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix are not excluded.
-
Significant liver disease, defined as having continuously elevated aspartate aminotransferase (AST SGOT) or alanine aminotransferase (ALT SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
-
Uncontrolled concomitant infections, severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption, active peptic ulcer, or any other unstable medical condition that could interfere with this study
-
Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant
-
Currently receiving any immunosuppressive agent
-
Anticipated contraindication to taking medications orally or via nasogastric tube by the morning of Day 2 following completion of the transplant procedure
-
Require certain medications
-
Known hypersensitivity to any of the study medications, thymoglobulin daclizumab, or corticosteroids
-
Certain screening laboratory values. More information on this criterion can be found in the protocol.
-
Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study
-
Anticipated contraindication to tacrolimus administration for longer than 5 days post-transplant
-
Currently undergoing peritoneal dialysis
-
PRA value less than 10% at any time prior to study entry
-
Graves disease. Patients with Graves disease adequately treated with radioiodine ablative therapy are not excluded.
-
Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) negative kidney recipient receiving a kidney from a CMV or EBV positive donor
-
Pregnancy or breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
- Immune Tolerance Network (ITN)
Investigators
- Principal Investigator: George W. Burke, III, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- DAIT ITN022ST
Study Results
Participant Flow
| Recruitment Details | One center in the United States enrolled nine subjects who were recipients of living-related (1-haplotype-matched) donor kidney transplants between September 2004 and November 2006. |
|---|---|
| Pre-assignment Detail | Participants underwent procedures at screening to establish inclusion/exclusion criteria. |
| Arm/Group Title | DBMCs | Control Group |
|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. |
| Period Title: Overall Study | ||
| STARTED | 4 | 5 |
| COMPLETED | 3 | 4 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | DBMCs | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Total of all reporting groups |
| Overall Participants | 4 | 5 | 9 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
4
100%
|
5
100%
|
9
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
41.0
(12.0)
|
41.8
(7.9)
|
41.4
(9.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
50%
|
0
0%
|
2
22.2%
|
| Male |
2
50%
|
5
100%
|
7
77.8%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
4
100%
|
5
100%
|
9
100%
|
Outcome Measures
| Title | Overall Participant Survival at One Year Post Kidney Transplant |
|---|---|
| Description | |
| Time Frame | One year post kidney transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat |
| Arm/Group Title | DBMCs | Control Group |
|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. |
| Measure Participants | 4 | 5 |
| Number [participants] |
4
100%
|
5
100%
|
| Title | Overall Kidney Graft Survival at One Year Post-Transplant |
|---|---|
| Description | Number of participants that did not experience kidney graft failure[1] at one year post-transplant [1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation. |
| Time Frame | One year post kidney transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat |
| Arm/Group Title | DBMCs | Control Group |
|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. |
| Measure Participants | 4 | 5 |
| Number [participants] |
4
100%
|
5
100%
|
| Title | Participant Survival at Three Years Post Kidney Transplant |
|---|---|
| Description | |
| Time Frame | Three years post kidney transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat |
| Arm/Group Title | DBMCs | Control Group |
|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. |
| Measure Participants | 4 | 5 |
| Number [participants] |
4
100%
|
5
100%
|
| Title | Graft Survival at Three Years Post-Transplant |
|---|---|
| Description | Number of participants that did not experience kidney graft failure[1] at three years post-transplant [1]Graft failure is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation. |
| Time Frame | Three years post kidney transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat |
| Arm/Group Title | DBMCs | Control Group |
|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. |
| Measure Participants | 4 | 5 |
| Number [participants] |
4
100%
|
5
100%
|
| Title | Number of Kidney Biopsy-proven Acute Rejection |
|---|---|
| Description | Biopsy-proven acute renal (kidney) rejection[1,2]. Diagnosis of acute rejection was made by renal 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, with higher scores indicating more severe rejection[2] Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999 |
| Time Frame | Three years post kidney transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who experienced an acute rejection |
| Arm/Group Title | DBMCs | Control Group |
|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. |
| Measure Participants | 1 | 1 |
| Number [Rejection Events] |
1
|
1
|
| Title | Number of Chronic Allograft Nephropathies |
|---|---|
| Description | Number of chronic allograft nephropathies[1,2,3] at 3 years post kidney transplant. Chronic allograft nephropathy is defined as renal biopsies with Banff 97 Grade I or greater[2] with higher numeric scores indicating more severe nephropathy The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification[3] Reference: Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999 |
| Time Frame | Three years post kidney transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who experienced nephropathies |
| Arm/Group Title | DBMCs | Control Group |
|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. |
| Measure Participants | 4 | 1 |
| Number [Nephropathy Events] |
6
|
2
|
| Title | Number of Graft-versus-host Disease (GVHD) Events |
|---|---|
| Description | A disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Symptoms include jaundice, skin rash or blisters, a dry mouth, or dry eyes. Also called graft-versus-host disease. |
| Time Frame | Three years post kidney transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat |
| Arm/Group Title | DBMCs | Control Group |
|---|---|---|
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. |
| Measure Participants | 4 | 5 |
| Number [GVHD Events] |
0
|
0
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | DBMCs | Control Group | ||
| Arm/Group Description | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information. | ||
All Cause Mortality |
||||
| DBMCs | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DBMCs | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 3/5 (60%) | ||
| General disorders | ||||
| Chest pain | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Pyrexia | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Immune system disorders | ||||
| Kidney transplant rejection | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Infections and infestations | ||||
| Tonsillitis | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Urinary tract infection | 2/4 (50%) | 2 | 0/5 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Drug toxicity | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Post procedural haematoma | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Investigations | ||||
| Blood creatinine increased | 3/4 (75%) | 12 | 2/5 (40%) | 2 |
| Renal and urinary disorders | ||||
| Glomerulonephritis membranoproliferative | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Mesangioproliferative glomerulonephritis | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Nephrotic syndrome | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Vascular disorders | ||||
| Hypertension | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| DBMCs | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 5/5 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 3/4 (75%) | 4 | 2/5 (40%) | 2 |
| Leukopenia | 1/4 (25%) | 1 | 1/5 (20%) | 1 |
| Neutropenia | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Cardiac disorders | ||||
| Palpitations | 2/4 (50%) | 2 | 0/5 (0%) | 0 |
| Tachycardia | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Hydrocele | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Ear and labyrinth disorders | ||||
| Ear pain | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Eye disorders | ||||
| Vision blurred | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Visual acuity reduced | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Constipation | 0/4 (0%) | 0 | 2/5 (40%) | 2 |
| Diarrhoea | 0/4 (0%) | 0 | 2/5 (40%) | 2 |
| Palatal oedema | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Stomatitis | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Swollen tongue | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Vomiting | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| General disorders | ||||
| Face oedema | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Oedema peripheral | 3/4 (75%) | 4 | 0/5 (0%) | 0 |
| Pain | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Pyrexia | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Infections and infestations | ||||
| Body tinea | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Fungal infection | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Gastroenteritis viral | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Herpes zoster | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Oral candidiasis | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Oral herpes | 2/4 (50%) | 2 | 0/5 (0%) | 0 |
| Upper respiratory tract infection | 2/4 (50%) | 2 | 2/5 (40%) | 2 |
| Urinary tract infection | 3/4 (75%) | 5 | 0/5 (0%) | 0 |
| Viral infection | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Investigations | ||||
| Blood alkaline phosphatase increased | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Blood triglycerides increased | 0/4 (0%) | 0 | 1/5 (20%) | 3 |
| Gamma-glutamyltransferase increased | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Hepatic enzyme increased | 1/4 (25%) | 1 | 3/5 (60%) | 3 |
| Platelet count decreased | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Platelet count increased | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Red blood cell count decreased | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| White blood cell count decreased | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Fluid overload | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Hypercholesterolaemia | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Hyperglycaemia | 1/4 (25%) | 1 | 2/5 (40%) | 3 |
| Hyperlipidaemia | 1/4 (25%) | 1 | 1/5 (20%) | 1 |
| Hypertriglyceridaemia | 0/4 (0%) | 0 | 3/5 (60%) | 4 |
| Hyperuricaemia | 0/4 (0%) | 0 | 1/5 (20%) | 2 |
| Hypocalcaemia | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Hypokalaemia | 2/4 (50%) | 3 | 0/5 (0%) | 0 |
| Hypomagnesaemia | 2/4 (50%) | 2 | 0/5 (0%) | 0 |
| Hypophosphataemia | 1/4 (25%) | 1 | 1/5 (20%) | 1 |
| Nervous system disorders | ||||
| Burning sensation | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Headache | 2/4 (50%) | 2 | 0/5 (0%) | 0 |
| Psychiatric disorders | ||||
| Insomnia | 0/4 (0%) | 0 | 2/5 (40%) | 2 |
| Renal and urinary disorders | ||||
| Bladder spasm | 1/4 (25%) | 1 | 1/5 (20%) | 1 |
| Dysuria | 1/4 (25%) | 1 | 1/5 (20%) | 1 |
| Glycosuria | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Haematuria | 1/4 (25%) | 1 | 1/5 (20%) | 1 |
| Pollakiuria | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Proteinuria | 3/4 (75%) | 4 | 2/5 (40%) | 3 |
| Reproductive system and breast disorders | ||||
| Menorrhagia | 1/4 (25%) | 3 | 0/5 (0%) | 0 |
| Ovarian cyst | 2/4 (50%) | 2 | 0/5 (0%) | 0 |
| Testicular pain | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchospasm | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Cough | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Dyspnoea | 2/4 (50%) | 2 | 1/5 (20%) | 1 |
| Oropharyngeal discomfort | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Oropharyngeal pain | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Pulmonary oedema | 0/4 (0%) | 0 | 1/5 (20%) | 1 |
| Tonsillar ulcer | 1/4 (25%) | 1 | 0/5 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Acne | 3/4 (75%) | 3 | 3/5 (60%) | 4 |
| Rash | 0/4 (0%) | 0 | 3/5 (60%) | 3 |
| Urticaria | 2/4 (50%) | 2 | 1/5 (20%) | 2 |
| Vascular disorders | ||||
| Hypertension | 2/4 (50%) | 3 | 4/5 (80%) | 6 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | George W. Burke III, M.D. |
|---|---|
| Organization | University of Miami |
| Phone | (305) 355-5060 |
| Gburke@med.miami.edu |
- DAIT ITN022ST