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

NCT06744335 | Active Not Recruiting

• 1 other identifier: D1843R00359
• Study Type: observational
• Target: 1,283
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Routine Therapy Before and After the Diagnosis of CKD; Demographic and Clinical Characteristics for Those Patients; Rate of CKD Diagnosis in Patients With AH and CKD Markers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  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.

  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.

  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).

  16 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• \* 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.

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (28)

Ordabasy Central District Hospital

Temirlanovka, Turkistan Oblast, Kazakhstan

Location

City Polyclinic No. 4

Aktobe, Kazakhstan

Location

City Cardiology Center

Almaty, Kazakhstan

Location

Interna Clinic, Scientific Centre for Internal Medicine LLP

Almaty, Kazakhstan

Location

JSC Research Institute of Cardiology and Internal Diseases

Almaty, Kazakhstan

Location

LLP Almaty Sema Hospital

Almaty, Kazakhstan

Location

Municipal state enterprise with the right of economic management City polyclinic No. 5

Almaty, Kazakhstan

Location

National Hospital of Medical Center of the Presidents Affairs Administration of the Republic of Kazakhstan

Almaty, Kazakhstan

Location

AIS Clinic

Astana, Kazakhstan

Location

City Polyclinic No. 2

Astana, Kazakhstan

Location

Family Health Center Shipager

Astana, Kazakhstan

Location

Green Clinic

Astana, Kazakhstan

Location

Medical Center Hospital of the President's Affairs Administration of the Republic of Kazakhstan

Astana, Kazakhstan

Location

Medical Center Zhanuya

Astana, Kazakhstan

Location

Onege Family Health and Happiness Centre, LLP

Astana, Kazakhstan

Location

State Enterprise on the Right of Economic Management City Polyclinic No. 5 Astana

Astana, Kazakhstan

Location

State Enterprise on the Right of Economic Management City Polyclinic No. 6 Astana

Astana, Kazakhstan

Location

UMC Diagnostic Centre

Astana, Kazakhstan

Location

Enbekshikazakh Multidisciplinary Interdistrict Hospital

Esik, Kazakhstan

Location

City Polyclinic No. 1

Karaganda, Kazakhstan

Location

City Polyclinic No. 3

Karaganda, Kazakhstan

Location

Communal State Enterprise Polyclinic No. 4 of Kostanay City

Kostanay, Kazakhstan

Location

Communal State Enterprise on the right of economic management City Polyclinic No. 7

Semey, Kazakhstan

Location

LLP Sau Zhurek Healthy Heart

Shymkent, Kazakhstan

Location

NJSC Heart Centre Shymkent

Shymkent, Kazakhstan

Location

IE Dr.Selina

Stepnogorsk, Kazakhstan

Location

Clinical and Diagnostic Center of the International Kazakh-Turkish University named after Khoja Ahmet Yasawi

Turkestan, Kazakhstan

Location

State Enterprise on the Right of Economic Management Zhambyl District Central Hospital

Uzynaghash, Kazakhstan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 20, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

KA (28)