E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitamin D deficiency in kidney transplant recipients |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047626 |
E.1.2 | Term | Vitamin D deficiency |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023438 |
E.1.2 | Term | Kidney transplant |
|
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 |
1. Does vitamin D3 substitution in vitamin D deficient kidney transplant recipients influence the posttransplant outcome compared to placebo?
Hypothesis 1a Vitamin D3 substitution improves graft function compared to placebo analysed by means of serum creatinine within the first year after transplantation. Another surrogate marker used to evaluate the immunomodulatory properties of vitamin D3 is the incidence of acute rejection episodes within the first year after kidney transplantation.
Hypothesis 1b Vitamin D3 substitution reduces the frequency and severity (analysed by means of CRP) of posttransplant infections compared to placebo within the first year after kidney transplantation.
|
|
E.2.2 | Secondary objectives of the trial |
2. Does vitamin D3 substitution influence renal osteopathy analysed using absolute bone mineral density?
Hypothesis 2 Vitamin D3 substitution prevents the usual decline in bone mineral density within the first year after transplantation |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age >18 Deceased donor kidney transplant recipients Only kidney transplant recipients Vitamin D deficiency defined as 25OHD <50nmol/l
|
|
E.4 | Principal exclusion criteria |
Re-transplantation for the second time if the patient is highly immunized and therefore included in the apheresis program Re-transplantation for the third time or more often Significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mukoviscidosis, Zollinger-Ellison-syndrom History of inflammatory bowel disease: Crohn’s disease, Ulcerative Colitis Previouse gastrectomy, small bowel or large bowel resection, intestinal bypass surgery Severe liver disease: cirrhosis HIV positive (HAART enhances Vitamin D catabolism)
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The immunologic effects of vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of - serum creatinine levels within the first year after transplantation, - number of acute rejection episodes within the first year after transplantation, - number of infections within the first year after transplantation, - and CRP levels within the first year after transplantation.
|
|
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 | No |
E.6.5 | Efficacy | No |
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 | No |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |