E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 diabetes and microalbuminuria. |
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E.1.1.1 | Medical condition in easily understood language |
Type 1 diabtes and early signs of kidney complikations |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037827 |
E.1.2 | Term | Raised serum uric acid |
E.1.2 | System Organ Class | 100000004848 |
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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 determine whether lowering serum uric acid by means of allopurinol early in the course of kidney disease may be effective in slowing the decline of renal function in T1D patients. |
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E.2.2 | Secondary objectives of the trial |
To evaluate if the albuminuria lowering effect correlates with changes in uric acid, 24 hour blood pressure, kidney function, HbA1c and inflammatory biomarkers for CVD. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female type 1 diabetes between 18 and 75 years of age, inclusive.
History or presence of microalbuminuria.
Estimated GFR > 50 ml/min/1.73 m2
Serum UA ≥ 0,265 mmol/L |
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E.4 | Principal exclusion criteria |
Known allergy to xanthine-oxidase inhibitors or allopurinol.
Already in Allopurinol treatment or indications for uric acid lowering therapy.
Use of urate-lowering agents within 3 months before screening.
Renal Calculi.
Current use of azathioprine, 6-mercaptopurine, didanosine, warfarin, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol.
Breastfeeding, pregnancy or unwillingness to be on contraception if still fertile.
Non-diabetic kidney disease. HIV or hepatitis.
Poor mental function or any other reason to expect patient difficulty incomplying with the requirements of the study. Serious pre-existing medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency.
Ongoing alcohol or drug abuse.
SBP > 180 or DBP > 110 mg
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in albuminuria (UAE): we expect a fall in albuminuria with allopurinol treatment compared to placebo. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Albuminuria after the first and second treament period of 60 days each. |
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E.5.2 | Secondary end point(s) |
Changes in arterial blood pressure and stabilisation or improved GFR during allopurinol treatment compared to placebo. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
GFR and Blood pressure mesured after the first and second treatment period of 60 days each. |
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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 | Yes |
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 | No |
E.8.1.6 | Cross over | Yes |
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 | 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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |