NCT01758042Completed
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
Combined Haploidentical Reduced Intensity Bone Marrow and Kidney Transplantation for Patients With Chronic Kidney Disease and Advanced Hematological Disorders
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
The main purpose of this study is to examine the outcome of a combined bone marrow and kidney transplant from a partially matched related (haploidentical or "haplo") donor. This is a pilot study, you are being asked to participate because you have a blood disorder and kidney disease. The aim of the combined transplant is to treat both your underlying blood disorder and kidney disease. We expect to have about 10 people participate in this study. Additionally, because the same person who is donating the kidney will also be donating the bone marrow, there may be a smaller chance of kidney rejection and less need for long-term use of anti-rejection drugs. Traditionally, very strong cancer treatment drugs (chemotherapy) and radiation are used to prepare a subject's body for bone marrow transplant. This is associated with a high risk for serious complications, even in subjects without kidney disease. This therapy can be toxic to the liver, lungs, mucous membranes, and intestines. Additionally, it is believed that standard therapy may be associated with a higher risk of a complication called graft versus host disease (GVHD) where the new donor cells attack the recipient's normal body. Recently, less intense chemotherapy and radiation regimens have been employed (these are called reduced intensity regimens) which cause less injury and GVHD to patients, and thus, have allowed older and less healthy patients to undergo bone marrow transplant. In this study, a reduced intensity regimen of chemotherapy and radiation will be used with the intent of producing fewer toxicities than standard therapy. Typical therapy following a standard kidney transplant includes multiple lifelong medications that aim to prevent the recipient's body from attacking or rejecting the donated kidney. These are called immunosuppressant drugs and they work by "quieting" the recipient's immune system to allow the donated kidney to function properly. One goal in our study is to decrease the duration you will need to be on immunosuppressant drugs following your kidney transplant as the bone marrow transplant will provide you with the donor's immune system which should not attack the donor kidney.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 17 Dec 2012
- Start date
- Nov 2012
- Primary completion date
- Jul 2023
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Acute lymphoblastic leukaemia, Chronic kidney disease, Amyloidosis, Myeloproliferative neoplasms, Hodgkin lymphoma, Sickle cell disease, Chronic myeloid leukaemia, Myelodysplastic syndromes, Thalassaemia, Chronic lymphocytic leukaemia, Multiple myeloma, Acute myeloid leukemia
- NCT number
- NCT01758042
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From Nov 2012 to the primary completion date, Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other investigational drug use at the time of enrollment
Other illness
- Active serious infection
- Serologic positivity for HIV, HCV, or HbsAg positivity
- Active serious infection
Lab values
- Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to rabbit serum in ATG)
Other
- ABO blood group incompatibility in the host-vs-graft direction
Who the study is looking for
- Patients ages 18-70
- Underlying hematological disorder which is potentially curable with allogeneic bone marrow transplantation. This includes, but is not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS), AL amyloidosis, diamond blackfan anemia, myelofibrosis or other myeloproliferative disease, sickle cell anemia, and thalassemia.
- Existence of haploidentical first degree relative who passes standard donor evaluations for bone marrow and kidney donation
- LVEF \> 40% as measured by echocardiography or MUGA
- FEV1, FVC, and DLCO \> 50% of predicted as measured by standard PFTs
- Total bilirubin \< 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all \< 5x institutions upper limit of normal
- ABO compatibility in the host vs. graft direction
- Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.
- Participants should be on dialysis or have an estimated or measured CrCl \< 35 ml/min
- Life expectancy greater than six months.
- Recipient ability to understand and provide informed consent
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.