Clinical trial NCT03194633: Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study
Official title: Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-06-21
Enrollment: 871
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are prescribed 60-mg nifedipine GITS (once per day) and meet the inclusion/exclusion criteria will be enrolled into the study.

Brief summary: Chronic kidney disease (CKD) and hypertension are two closely related common chronic diseases that have serious implications to human health. Hypertension is a major cause for progression of renal disease and a risk factor for cardiovascular disease (CVD). Control of Blood Pressure (BP) to target is now considered to be the main goal in the treatment of patients with CKD.

In clinical practice, it is difficult for CKD patients with hypertension to achieve systolic BP (SBP) or diastolic BP (DBP) goal; oftentimes, calcium channel blocker (CCB) class of drugs, for example, nifedipine gastrointestinal therapeutic system (GITS), is used in such patients. Previous data have demonstrated nifedipine to be having a significant dose-response relationship; that is, nifedipine 60 mg provided better BP reduction than 30 mg. However, there are limited studies that have evaluated the efficacy and tolerability of nifedipine GITS 60 mg in Chinese CKD patients with hypertension. Hereby, the objective of this study was to evaluate the effectiveness and tolerability of nifedipine GITS 60 mg treatment in a large cohort of CKD patients with uncontrolled hypertension.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18-70 years
* Patients diagnosed with CKD (Estimated Glomerular Filtration Rate (eGFR) \>15 mL/min/1.73 m\*2) and hypertension without dialysis/replacement therapy
* Patients with uncontrolled hypertension (office SBP ≥140 mmHg and DBP ≥ 80 mmHg) who have received Renin-Angiotensin System Inhibitors (RASI) treatment or have not received RASI treatment because of any contraindications
* Patients who haven't received nifedipine GITS 60 mg (once per day) previously
* Patients for whom the decision to initiate treatment with nifedipine GITS 60 mg was made as per the investigator's routine treatment practice
* Signed informed consent
* No participation in an investigational program with interventions outside of routine clinical practice

Exclusion Criteria:

* Have a contraindication to nifedipine GITS according to the approved prescribing information
* Patients participating in an investigational program with interventions outside of routine clinical practice

Primary outcomes:
measure: Change in office systolic blood pressure from baseline to week 12
timeFrame: At week 12
Secondary outcomes:
measure: Change in office diastolic blood pressure from baseline to week 12
timeFrame: At week 12
measure: Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 according to baseline SBP stratification
timeFrame: At week 12
measure: Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney Disease
timeFrame: At week 12
measure: Systolic blood pressure and diastolic blood pressure control rate at week 12
timeFrame: At week 12
measure: Number of participants with adverse events and serious adverse events
timeFrame: At week 12
Other outcomes:
Locations:
city: Multiple Locations
country: China
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Lv R, Chen J, Wang H, Wang J, Cheng H, Li R, Li W, Zhang T, Wei L, Chen Q, Huang J, Yu F, Shen S, Wu H, Liu C, Hong F, Liu J, Zhang X, Xiao H, Song W. Effectiveness and Tolerability of Nifedipine GITS in Patients with Chronic Kidney Disease and Uncontrolled Hypertension: A Prospective, Multicenter, Observational Study (ADRENAL). Adv Ther. 2021 Sep;38(9):4771-4785. doi: 10.1007/s12325-021-01850-3. Epub 2021 Jul 30.