K Heart And Renal Protection Study III

Phase 1

• Conditions: Chronic kidney disease; MedDRA version: 18.1Level: HLTClassification code 10038443Term: Renal failure and impairmentSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2013-004205-89-GB
• Lead Sponsor: Oxford Radcliffe Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-28
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age >=18 years.
2. Estimated glomerular filtration rate (eGFR) >=20 and <45 mL/min/1.73m^2 OR
3. eGFR >=45 and <60 mL/min/1.73m^2 AND Urine albumin:creatinine ratio (ACR) >=20 mg/mmol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. Angiotensin receptor blocker (ARB) therapy contraindicated.
2. Known intolerance of ARB therapy.
3. Current use of direct renin inhibitor aliskiren
4. Systolic blood pressure >180 mmHg at Screening visit.
5. Serum potassium >5.5 mmol/L at Screening visit.
6. Presence of nephrotic syndrome (defined as ACR >300 mg/mmol and serum albumin <30 g/L) or receiving immunosuppression as treatment of nephrotic syndrome at Screening.
7. Functioning renal transplant.
8. Acute coronary syndrome, stroke or transient ischaemic attack in previous 3 months prior to Screening.
9. Known chronic liver disease (or ALT >2x upper limit of normal at Screening).
10. History of angioedema.
11. Use of unlicensed medicinal product in previous month.
12. Pregancy or women with child-bearing potential (refusing a reliable method of contraception).
13. Other medical history that might limit the patient's ability to take study treatments for the duration of the study (eg, recent history of alcohol or substance misuse, severe respiratory disease).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified