Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients
The purpose of the study is to learn if islet transplantation is an effective treatment for Type 1 diabetes in people who have had a kidney transplant.
The primary objectives of the study are:
- To set up islet transplantation in patients who have had a kidney transplant and who are using an immunosuppressive regimen that works
The Secondary objective of the study is:
- To find out if successful islet transplantation leads to improved metabolic control and reduced renal complication from diabetes
調査の概要
詳細な説明
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2doses of basiliximab.
All patients will receive Etanercept to promote engraftment.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male and female subjects
- Age 18 to 70 years of age
- Have insulin dependent Diabetes Mellitus Type 1
- Are post-renal transplant on maintenance immunosuppression with stable renal function
- HbA1c > 7.5% or < 7.5% and hypoglycemia unawareness
Exclusion Criteria:
- Weight more than 90 kg
- Insulin requirement > 60 Units/day
- Other (non-kidney) organ transplants except prior failed pancreatic graft.
- Untreated or unstable proliferative diabetic retinopathy
- Presence of de novo antibody production since the renal allograft or either Class I or Class II panel-reactive anti-HLA antibodies
- Active infection
- Negative screen for Epstein-Barr virus (EBV)
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- History of Factor V Leiden mutation
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g. warfarin) after transplantation (low-dose aspirin treatment is allowed) or subjects with international normalized ratio (INR) > 1.5
- Severe co-existing cardiac disease
- Persistent elevation of liver function tests at the time of study entry
- Acute or chronic pancreatitis
- Male subjects with elevation of prostate specific antigen
- Pregnancy
- Positive screen for polyoma (BK) virus
- Untreated hyperlipidemia
- Recent hemorrhagic stroke
- Factors associated with an increased risk of bleeding
Contact PI for complete Incl-Excl criteria list.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Islet transplant
Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence. For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft. Induction therapy for subsequent transplants will be 2 doses of basiliximab. All patients will receive Etanercept to promote engraftment. |
Islet after kidney transplant in patients with type I diabetes.
Given as induction for islet cell transplant
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Insulin Independence With Both an HbA1c ≤ 6.5% and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant or a Reduction in HbA1c of at Least 1 Point and no Severe Hypoglycemic Events at 1 Year After the First Islet Transplant.
時間枠：1 year after the subject's first islet transplant
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1 year after the subject's first islet transplant
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With a Decrease in HbA1c
時間枠：1 year after subject's first islet transplant
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Subjects will have a decrease in HbA1c of at least >1%
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1 year after subject's first islet transplant
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Stable or Decrease in Urinary Albumin and Creatinine Ratio and Serum Creatinine
時間枠：1 year after subjects initial islet transplant
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Proteinuria and serum creatinine will be stable or decreased as compared to pre-transplant values
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1 year after subjects initial islet transplant
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An Absence Cardiovascular Events, Cerebral Vascular Accident, and Myocardial Infarction
時間枠：1 year after the subject's first islet transplant
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1 year after the subject's first islet transplant
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|
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Impact on Vision
時間枠：1 year after the subject's first islet transplant
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Improvement of frequency of interventions and from changes in reported visual acuity with optical refraction and severity of diabetic retinopathy
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1 year after the subject's first islet transplant
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Absence of Negative Renal Impact Measures
時間枠：1 year after the subject's first islet transplant
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Loss of allograft survivial (return to dialysis, retransplant, death) and Renal allograft function meausred by SCr
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1 year after the subject's first islet transplant
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Improvement of Metabolic Control
時間枠：1 year after the subject's first islet transplant
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Whether there is an improvement in metabolic control in IAK will be evaluated based on improvement in
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1 year after the subject's first islet transplant
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Number of Participants With a Decrease of Severe Hypoglycemic Events
時間枠：1 year after subject's first transplant
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Subjects will have a decrease in severe hypoglycemic events
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1 year after subject's first transplant
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Reduction of Insulin Requriements
時間枠：1 year after the subject's first islet transplant
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Evidence of partial success will be considered for subjects who have a reduction in insulin requirements but who are not insulin independent.
This will be assessed by comparing the pre-transplant insulin requirement expressed as insulin units per kg per day with the requirement preceding subsequent islet transplants and the insulin requirements at 6 months and 1, 2, and 3 years after the first and last transplant.
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1 year after the subject's first islet transplant
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協力者と研究者
捜査官
- 主任研究者：James F Markmann, MD, PhD、Massachusetts General Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
I型糖尿病の臨床試験
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Centre Hospitalier Universitaire, Amiens募集