Prospective Observational Multicenter Study of Patients With AH and CKD Markers in Kazakhstan (PROGRESS-CKD) (D1843R00359)

Prospective Observational Multicenter Study of Patients With Arterial Hypertension and Chronic Kidney Disease Markers in Kazakhstan (PROGRESS-CKD)

Multicenter, non-interventional PRospective Observational study with retrospective analysis to describe the rate of CKD diaGnosis in patients with aRtErial hypErtenSion and CKD markerS in Kazakhstan

Study Overview

• Status: Active, not recruiting
• Conditions: Rate of CKD Diagnosis in Patients With AH and CKD Markers; Demographic and Clinical Characteristics for Those Patients; Routine Therapy Before and After the Diagnosis of CKD

Detailed Description

Primary endpoints:

The proportion of patients with markers of chronic kidney disease (CKD) among patients with arterial hypertension such as: albuminuria/proteinuria; GFR <60 ml/min/1.73 m2 (CFR categories C3a-C5).

Secondary endpoints:

The following secondary endpoints will be evaluated in all patients with AH and markers of CKD included in the study (Full Analysis Sampling - FAS) (Secondary Aim 1) and in the subgroup of patients with a diagnosis of CKD confirmed during the study (Modified Full Analysis Sampling - mFAS), i.e., at Visit 1 or

Visit 2 (Secondary Aim 2):

• Study Type: Observational
• Enrollment (Actual): 1283

Contacts and Locations

Study Locations

• Kazakhstan
  • Aktobe, Kazakhstan
    • City Polyclinic No. 4
  • Almaty, Kazakhstan
    • JSC Research Institute of Cardiology and Internal Diseases
  • Almaty, Kazakhstan
    • Municipal state enterprise with the right of economic management City polyclinic No. 5
  • Almaty, Kazakhstan
    • City Cardiology Center
  • Almaty, Kazakhstan
    • Interna Clinic, Scientific Centre for Internal Medicine LLP
  • Almaty, Kazakhstan
    • LLP Almaty Sema Hospital
  • Almaty, Kazakhstan
    • National Hospital of Medical Center of the Presidents Affairs Administration of the Republic of Kazakhstan
  • Astana, Kazakhstan
    • Medical Center Hospital of the President's Affairs Administration of the Republic of Kazakhstan
  • Astana, Kazakhstan
    • AIS Clinic
  • Astana, Kazakhstan
    • City Polyclinic No. 2
  • Astana, Kazakhstan
    • Family Health Center Shipager
  • Astana, Kazakhstan
    • Green Clinic
  • Astana, Kazakhstan
    • Medical Center Zhanuya
  • Astana, Kazakhstan
    • Onege Family Health and Happiness Centre, LLP
  • Astana, Kazakhstan
    • State Enterprise on the Right of Economic Management City Polyclinic No. 5 Astana
  • Astana, Kazakhstan
    • State Enterprise on the Right of Economic Management City Polyclinic No. 6 Astana
  • Astana, Kazakhstan
    • UMC Diagnostic Centre
  • Esik, Kazakhstan
    • Enbekshikazakh Multidisciplinary Interdistrict Hospital
  • Karaganda, Kazakhstan
    • City Polyclinic No. 1
  • Karaganda, Kazakhstan
    • City Polyclinic No. 3
  • Kostanay, Kazakhstan
    • Communal State Enterprise Polyclinic No. 4 of Kostanay City
  • Semey, Kazakhstan
    • Communal State Enterprise on the right of economic management City Polyclinic No. 7
  • Shymkent, Kazakhstan
    • LLP Sau Zhurek Healthy Heart
  • Shymkent, Kazakhstan
    • NJSC Heart Centre Shymkent
  • Stepnogorsk, Kazakhstan
    • IE Dr.Selina
  • Turkestan, Kazakhstan
    • Clinical and Diagnostic Center of the International Kazakh-Turkish University named after Khoja Ahmet Yasawi
  • Uzynaghash, Kazakhstan
    • State Enterprise on the Right of Economic Management Zhambyl District Central Hospital
  • Turkistan Oblast
    • Temirlanovka, Turkistan Oblast, Kazakhstan
      • Ordabasy Central District Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The planned study population for the prospective analysis consists of 1,282 adult outpatients with AH with one or more markers of CKD, without a documented diagnosis of CKD before inclusion in the study and without a documented diagnosis of DM or III-IV stage chronic heart failure (CHF). The planned number of study centers is ~15 outpatient sites in approximately 10 regions of Kazakhstan.

The retrospective part includes a physician's retrospective review of the ambulatory cards or medical records of outpatients with a reported diagnosis of arterial hypertension for the presence of laboratory markers of CKD assessed ≥3 and ≤12 months prior to inclusion.

Description

Inclusion Criteria:

Age ≥18 years at the time of inclusion;

• Patient signed and dated written informed consent form (ICF) in accordance with ICH GCP and local legislation prior to inclusion in the study for the prospective observational cohort;
• Established diagnosis of hypertension, diagnosed in accordance with current clinical guidelines for hypertension, i.e. in adults, i.e. systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg. when measured at two different visits

• Laboratory markers of CKD (eGFR <60 mL/min/1.73 m2 and/or albuminuria/proteinuria*) measured during the period ≤12 months prior to inclusion in the study and persisting ≥3 months between two measurements without a recorded diagnosis of CKD in the primary medical record prior to inclusion;

  * any of the following: urine albumin/creatinine ratio (UACR) ≥30 mg/g (3 mg/mmol), Urine protein-creatinine ratio (uPCR) ≥150 mg/g (15 mg/mmol), albuminuria ≥30 mg/d or Urine protein-creatinine ratio (uPCR) ≥0.15 mg/d.

• Absence of documented diagnosis of CKD in the patient's medical records prior to inclusion in the study

Exclusion Criteria:

• Absence of a signed ICF in patients in the prospective follow-up group

  • Participation in any randomized controlled trial within 3 months prior to inclusion in this study or during participation in this study
  • An established diagnosis of type 1 or type 2 diabetes mellitus.
  • Diagnosis of symptomatic chronic heart failure (CHF), NYHA functional class III-IV, documented in the patient's medical records
  • Diagnosis of AH of secondary genesis

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with markers of chronic kidney disease (CKD) among patients with arterial hypertension such as: albuminuria/proteinuria; GFR <60 ml/min/1.73 m2 (CFR categories C3a-C5).	The proportion of patients with markers of chronic kidney disease (CKD) among patients with arterial hypertension such as: albuminuria/proteinuria; GFR <60 ml/min/1.73 m2 (CFR categories C3a-C5).	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Frequency of microalbuminuria, proteinuria, reduced glomerular filtration rate (GFR <60 ml/min/1.73 m²) and other markers of kidney damage in patients with arterial hypertension.	1. Frequency of microalbuminuria, proteinuria, reduced glomerular filtration rate (GFR <60 ml/min/1.73 m²) and other markers of kidney damage in patients with arterial hypertension.	16 months
2. Proportion of patients with various risk factors (age, gender, BMI, bad habits, blood pressure, cardiovascular risks) for the development and progression of CKD in patients with arterial hypertension.	2. Proportion of patients with various risk factors (age, gender, BMI, bad habits, blood pressure, cardiovascular risks) for the development and progression of CKD in patients with arterial hypertension.	16 months
3.Proportion of patients with various clinical characteristics, such as: • Average and median duration of AH years • Patients with different stages of AH and categories of cardiovascular risk.• Patients with uncontrolled and resistant hypertension.	3. Proportion of patients with various clinical characteristics, such as: Average and median duration of hypertension, years (from the diagnosis date to Visit 1);; Patients with different stages of hypertension (I, II, III) and categories of cardiovascular risk (low, moderate, high, very high).; Patients with uncontrolled and resistant hypertension.	16 months
4. The proportion of patients taking the following groups of drugs for the treatment of AH before inclusion in the study and during participation in the study: • ACE • Alfa or Beta-blockers; • ARBs •CCB • Diuretics • ARNI• Centrally acting drugs; • MRA.	4. The proportion of patients taking the following groups of drugs for the treatment of hypertension before inclusion in the study and during participation in the study: ACE (angiotensin-converting enzyme) inhibitors;; Beta-blockers;; ARBs (angiotensin receptor blockers);; Calcium channel blockers (CCB);; Diuretics (thiazide, thiazide-like, loop);; Angiotensin receptor-neprilysin inhibitor (ARNI);; Alpha-blockers;; Centrally acting drugs;; Mineralocorticoid receptor antagonists (MRA).	16 months
5. Proportion of patients with: • concomitant CVD and complications of AF/AFL, ventricular arrhythmias; CHD; MI; cerebrovascular diseases; stroke, TIA; • other concomitant diseases (in general and for each disease).	5. Proportion of patients with: concomitant cardiovascular diseases (CVD) and complications of hypertension (atrial fibrillation/atrial flutter (AF/AFL), ventricular arrhythmias; coronary heart disease (CHD); myocardial infarction (MI); cerebrovascular diseases; stroke, transient ischemic attack (TIA);; other concomitant diseases (in general and for each disease).	16 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: D1843R00359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.