E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Proteinuria in kidney transplant recipients |
Proteinurija pri bolnikih po presaditvi ledvice |
|
E.1.1.1 | Medical condition in easily understood language |
Excretion of proteins in the urine in kidney transplant recipients |
Izločanje beljakovin v seču pri bolnikih s presajeno ledvico |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 |
Difference in urinary protein to creatinine ratio (UPCR) between paricalcitol and placebo study group patients. |
Razlika v vrednosti razmerja beljakovine/kreatinin (UPCR) med prejemniki parikalcitola in placeba. |
|
E.2.2 | Secondary objectives of the trial |
The proportion of patients achieving at least a 15 mg/mmol reduction in the last on-treatment UPCR level form the baseline.
Difference in urinary albumin to creatinine ratio (UACR) between paricalcitol and placebo study groups.
Difference in 24-hour urinary protein excretion between paricalcitol and placebo study groups.
|
Delež bolnikov, pri katerih bo vrednost UPCR za vsaj 15 mg/mmol manjša v primerjavi z izhodiščno vrednostjo.
Razlika v vrednosti razmerja albumin/kreatinin (UACR) med prejemniki parikalcitola in placeba.
Razlika v količini izločenih beljakovin v 24-urnem seču med prejemniki parikalcitola in placeba. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Recipients of a deceased donor kidney transplant at least three months after transplantation. Patients are on stable immunosuppression at least three months before study enrollment. Recipient age ≥ 18 years. Patients are on stable doses of antihypertensive medications for at least three months before study enrollment. Patients are not expected to begin dialysis for at least six months. Estimated glomerular filtration rate > 15 mL/min/1.73 m2. UPCR > 22 mg/mmol (> 200 mg/g), as determined by the geometric mean of three second morning void urine samples. Corrected serum calcium concentration ≤ 2.5 mmol/L. Intact parathoromone concentration > 35 pg/mL. |
Prejemniki ledvice umrlega darovalca vsaj 3 mesece po presaditvi. Jemanje nespremenjene imunosupresije vsaj tri mesece pred vključitvijo v raziskavo. Starost ≥ 18 let. Stabilna antihipertenzivna terapija vsaj 3 mesece pred prvim obiskom. Pričakovana neodvisnost od nadomestnega zdravljenja z dializo vsaj 6 mesecev. Ocenjena glomerulna filtracija > 15 mL/min/1.73 m2. UPCR > 22 mg/mmol (> 200 mg/g), izračunano z geometrično sredino treh zaporednih vzorcev drugega jutranjega seča. Koncentracija korigiranega kalcija ≤ 2.5 mmol/L. Koncentracija intaktnega parathormona > 35 pg/mL. |
|
E.4 | Principal exclusion criteria |
Patients on vitamin D receptor activation therapy within three months prior to the first study visit. Patients with diagnosis of primary focal segmental glomerulosclerosis (FSGS). Patients with acute kidney injury within three months prior to the first study visit. Patients with poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg). |
Zdravljenje z agonisti receptorjev vitamina D v zadnjih 2 mesecih. Bolniki s primarno fokalno segmentno glomerulosklerozo (FSGS). Akutna ledvična okvara znotraj 2 mesecev pred prvim obiskom. Slabo urejena arterijska hipertenzija (sistolični krvni tlak ≥ 160 mmHg in/ali diastolični krvni tlak ≥ 100 mmHg).
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Difference in urinary protein to creatinine ratio (UPCR) in second morning void urine between paricalcitol and placebo study group patients after 24 weeks of treatment. |
Razlika v vrednosti razmerja beljakovine/kreatinin (UPCR) v vzorcu drugega jutranjega seča med prejemniki parikalcitola in placeba po 24 tednih zdravljenja. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
The proportion of patients achieving at least a 15 mg/mmol reduction in the last on-treatment UPCR level form the baseline.
Difference in urinary albumin to creatinine ratio (UACR) in second morning void urine between paricalcitol and placebo study groups after 24 weeks of treatment.
Difference in 24-hour urinary protein excretion between paricalcitol and placebo study groups after 24 weeks of treatment. |
Delež bolnikov, pri katerih bo vrednost UPCR po 24 tednih zdravljenja za vsaj 15 mg/mmol manjša v primerjavi z izhodiščno vrednostjo.
Razlika v vrednosti razmerja albumin/kreatinin (UACR) v vzorcu drugega jutranjega seča med prejemniki parikalcitola in placeba po 24 tednih zdravljenja.
Razlika v količini izločenih beljakovin v 24-urnem seču med prejemniki parikalcitola in placeba po 24 tednih zdravljenja. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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) | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
Last visit of the last subject |
Zadnji obisk zadnjega bolnika |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |