Chronic kidney disease and arterial hypertension with proteinuria. MedDRA version: 14.1 Level: PT Classification code 10037032 Term: Proteinuria System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Zanipress 20 mg/ 10 mg
Product Name: Zanipress
Product Code: Zanipress
Pharmaceutical Form: Coated tablet
INN or Proposed INN: NA
CAS Number: 132866-11-6
Current Sponsor code: LERCANIDIPIN
Sponsors
Universidad de Salamanca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be competent to provide written informed consent. Subjects must sign an IRB approved ICF and HIPAA Authorization prior to the initiation of any study procedures. All men must be informed of the potential risks associated with taking study drug, and queried regarding their understanding of the potential risks as described in the ICF. 2. Subjects must be 18 to 75 years of age. 3. Subject must have hypertension as defined by The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) for subjects with CKD, average sitting BP at Screening must be SBP >=135 or DBP >= 85 mmHg after three measurements on the same visit. 4. All screened subjects also will have albuminuria >200 mg/d (or 200 mg/g creatinine). The result of an analysis performed up to three months before basal visit is valid. 5. At Screening and prior to randomization, subjects must be receiving, and adhering to, full doses of an ACE-inhibitor or an angiotensin receptor blocker. For the purposes of this study, a full dose is defined as the highest labeled dose for the hypertension indication, the highest usual dose prescribed for hypertension per JNC 7 guidelines, or the highest tolerated dose of antihypertensive agent for that given subject. 6. Subjects must have an eGFR of >=30 mL/min/1.73 m2 at Screening. The result of an analysis performed up to three months before basal visit is valid. 7. Women of childbearing potential must have a negative urine pregnancy test at the time of randomization. Women who are post-menopausal for at least two years or surgically sterile are not considered to be of childbearing potential. Women of childbearing potential must also agree to use a reliable double-barrier method of contraception throughout participation in the study and for at least four weeks following the final study visit. A reliable double-barrier method of contraception is considered to be the concomitant use of two of the following: birth control pills/implants/injections, intrauterine devices, vaginal spermicide, diaphragms, or condoms. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 178 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Subjects with an average sitting SBP of ?180 mmHg or DBP of ?110 mmHg at Screening. 2. Subjects who have experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within six months of the Screening Visit. 3. Subjects with a history of renal transplant. 4. Subjects with severe hepatic disfunction. 5. Subjects with symptomatic CHF requiring treatment. 6. Subjects with hemodynamically significant valvular heart disease. 7. Subjects who are pregnant or nursing. 8. Subjects who have demonstrated non-compliance with previous medical regimens. 9. Albuminuria > 5.000 mg/day. The result of an analysis performed up to three months before basal visit is valid. 10. Subjects with a contraindication to treatment with ACE inhibitors, ARBs or calcium channel blockers. 11. Subjects who have participated in a clinical study involving another investigational drug or device within one month of the Screening Visit. 12. Subjects who have any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or severely limit the subject?s lifespan or ability to complete the study (e.g., alcohol or drug abuse, disabling or terminal illness, mental disorders).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of the enalapril-lercanidipine combination to protect renal function and reduce albuminuria;Secondary Objective: Compare the effects of the combination of enalapril-lercanidipine with the enalapril-amlodipine combination.;Primary end point(s): 1.Changes in renal function: will be evaluated through changes on serum creatinine, creatinine clearance, estimated GFR and serum cystatin C levels. Cystatin will be evaluated at balas visit (0), month 3 (90), 90, 180 and 360 days visit. For GFR estimation CKD-EPI and MDRD-4 equations will be used. 2.Microalbuminuria should be measured using 24h urine collections on follow up visits. 3.Blood pressure will be measured with a validated electronic device (Omron 705 ® or similar). Three measurements, taken at 3-min intervals in the sitting position, will be averaged and used as the clinical BP reference value. Heart rate would be measured from the radial pulse during 30 sec. Measurements will be performed at follow up visits.;Timepoint(s) of evaluation of this end point: Basal, month1, month 3, month 6, month 9 and month 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: to evaluate safety of the treatments adverse events occurred during the trial will be collected for both treatment arms.;Timepoint(s) of evaluation of this end point: Month1, month 3, month 6, month 9 and month 12. | — |
Countries
Spain
Contacts
Public ContactNicolas R. Robles
Hospital Infanta Cristina
Outcome results
None listed