E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
End Stage Renal Disease patients receiving continuous ambulatiry peritoneal dialysis (CAPD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014646 |
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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 |
The primary objective of this study is to demonstrate the non-inferiority of Extraneal Physiological pH compared to current Extraneal with regard to long dwell ultrafiltration
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to demonstrate the equivalence of Extraneal Physiological pH to current Extraneal with regard to acid-base status and the non-inferiority of Extraneal Physiological pH compared to current Extraneal with regard to long dwell peritoneal creatinine clearance
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients who have given written informed consent after the nature of the study has been explained. 2. Patients who are at least 18 years of age. 3. Patients who have been treated with CAPD with Physioneal 40 or Dianeal PD4 and current Extraneal for at least 60 days before the baseline visit (week –2).
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E.4 | Principal exclusion criteria |
1. Patients who have received antibiotics for the treatment of an episode of peritonitis within 30 days before the screening visit (week –4). Peritonitis being defined as 2 out of 3 of the following criteria: a) Cloudy peritoneal effluent with peritoneal white blood cell (WBC) count > 100 cells/mm3 due predominately to neutrophils (>50%), (≥ 1L dialysate after ≥ 2h dwell time). b) Signs and symptoms of peritoneal inflammation (e.g., abdominal pain). c) Demonstration of microorganism or yeast in the peritoneal effluent by culture or Gram’s stain. 2. Patients who have had acute or chronic exit-site or tunnel infection in the past 14 days, counted from the last day of infection to the screening visit (week –4). 3. Patients who have other serious diseases, such as active, or if previously treated, residual malignancy or systemic infection. 4. Patients who have had a major illness or injury requiring hospitalisation within 30 days before the baseline visit (week –2). 5. Patients who have severe malnutrition (serum albumin < 25 g/l by bromocresol green method). 6. Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted. 7. Patients who have received an investigational product within 30 days preceding the screening visit. 8. Patients who are pregnant or lactating. (NB: Female patients of childbearing potential must have a negative urine or serum pregnancy test at the time of the screening and will be required to use a medically acceptable means of contraception during their participation in this study). 9. Patients who have a significant psychiatric disorder or mental disability that could interfere with his/her ability to provide informed consent and/or comply with protocol procedures. 10. Patients who routinely add sodium bicarbonate to the dialysis bags or uses oral sodium bicarbonate. 11. Patients who routinely use Nutrineal (1.1% amino acid based solution) and cannot have this omitted from his/her regimen for the 10 week study period. 12. Patients who are allergic to starch-based polymers. 13. Patients who have glycogen storage disease. 14. Patients who have had abdominal surgery within 30 days preceding the screening visit (V0). 15. Patients who have had abdominal fistulae, tumours, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, abdominal surface or intra-abdominal cavity within 30 days preceding the screening visit (V0). 16. Patients who have maltose or isomaltose intolerance. 17. Patients who have other serious acute or active conditions that in the investigator's opinion would preclude their participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Ultrafiltration for the long dwell determined by weighing the overnight dialysis bags for seven days before the 2-weekly clinic visits and calculating the mean of the measurements |
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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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |