Clinical Trial: Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Combined Haploidentical Reduced Intensity Bone Marrow and Kidney Transplantation for Patients With Chronic Kidney Disease and Advanced Hematological Disorders
Brief Summary:
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.
Detailed Summary:
Sponsor: Massachusetts General Hospital
Current Primary Outcome: Number of patients who die of treatment-related complications. [ Time Frame: 100 days and 1 year post transplant ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Number of patients with acute and delayed renal allograft rejection [ Time Frame: 2 years post-transplant ]
Original Secondary Outcome: Same as current
Information By: Massachusetts General Hospital
Dates:
Date Received: December 17, 2012
Date Started: November 2012
Date Completion: July 2021
Last Updated: March 21, 2017
Last Verified: March 2017
