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NCT Number: NCT03194633

Effectiveness and Tolerability of Long-Acting Nifedipine Gastrointestinal Therapeutic System in Chronic Kidney Disease With Uncontrolled Hypertension Patients, a Prospective, Multicenter, Observational Study

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)

Drug

Nifedipine GITS 60 mg (once per day)

Primary outcomes

  1. Change in office systolic blood pressure from baseline to week 12

    Time frame: At week 12

    Change in office systolic blood pressure from baseline to week 12

Secondary outcomes

  1. Change in office diastolic blood pressure from baseline to week 12

    Time frame: At week 12

    Change in office diastolic blood pressure from baseline to week 12

  2. Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 according to baseline SBP stratification

    Time frame: At week 12

    Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 according to baseline SBP stratification, stratified by two subgroups baseline, SBP 140-160 mmHg and ≥ 160 mmHg

  3. Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney Disease

    Time frame: At week 12

    Change in systolic blood pressure and diastolic blood pressure from baseline to week 12 at different stages of Chronic Kidney Disease, stage 1 to stage 5

  4. Systolic blood pressure and diastolic blood pressure control rate at week 12

    Time frame: At week 12

    Systolic blood pressure and diastolic blood pressure control rate at week 12

  5. Number of participants with adverse events and serious adverse events

    Time frame: At week 12

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Acronym: ADRENAL

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2017
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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