E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type-I Diabetes Mellitus in renal trasplant patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | pt |
E.1.2 | Classification code | 10061835 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy and safety of the pancreatic islet cells transplantation from a cadaver donor, in the glycemic control of patients with Type-I Diabetes Mellitus and renal transplant, through its implantation into the liver by percutaneous portal vein catheterization. |
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E.2.2 | Secondary objectives of the trial |
To evaluate "the dose of pancreatic islet cells" in the use of such therapy. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
. Type-I diabetes mellitus patients with renal transplantation and good renal function (serum creatinine < 2 mg/dl, creatinine clearance > 40 ml/min and proteinuria < 1 gr/day). . Patients who were indicated a renal but not a pancreas transplantation because of the high-risk for surgery. For these patients renal and pancreatic islet cells transplant will be performed at the same time. . Patients between 18 and 65 years of age. . C-peptide levels < 0.48 ng/ml. . Body Mass Index (BMI) < 28 kg/m2 . Time of renal transplantantion of at least 6 months. |
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E.4 | Principal exclusion criteria |
. Deliberate desire not to take part in the trial. . Negative to sign the informed consent, essetial to take part in the Trial. . Presence of higher cardiovascular risks: ischemic cardiopathy, peripheral vasculopathy (amputation and/or intermittent claudication) and left ventricular dysfunction (LVEF left ventricular ejection fraction <30%). . Consumption of alcohol or any other substance abuse, including tobacco (abstinence is required for a period of at least 6 months). . Active infections (hepatitis B and C, HIV, tuberculosis, etc.). . Presence of neoplasia within 5 years prior to the transplantation, excluding nonmelanoma skin carcinomas. . Hepatic disease or hepatic disorders (ie. portal hypertension detected by ecographic control). . Presence of motor neuropathy or autonomic impairment. . Presence of coagulation disorders. . Presence of Leukopenia <3000/mm3 or thrombopenia <100.000/mm3. . Renal failure (creatinine clearance <60 ml/min or macroalbuminuria), except when performed together with the renal transplant. . Non-treated proliferative retinopathy . . Women who are pregnant or breast-feeding, or women with child-bearing potential who are not using effective contraceptive methods. . Daily insulin requirement > 0.7 U/kg/day. . HbA1c > 12%. . Uncontrolled hyperlipidemia. . Obesity. . Any other medical situation which in the investigator’s opinion could interfere with optimum participation in the trial or cause significant risk for the patient.
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E.5 End points |
E.5.1 | Primary end point(s) |
. Proportion of patients who get the control of gylcemic levels without the administration of any exogenous insulin in the post-transplant period, in Type-I diabetes mellitus patients with renal transplantation.
. Correlation between pre-trasplant and post-transplant blood glucose levels, and the control of insulin secretion in response to blood glucose after pancreatic islets transplant. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |