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Efficacy of the essential amino acids and keto-Analogues on the CKD progression rate

Efficacy of the essential amino acids and keto-analogues on the CKD progression rate in real practice in Russia - City Nephrology Registry Data for Outpatient Clinic

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN28190556
Enrollment
90
Registered
2016-05-06
Start date
2014-03-01
Completion date
Unknown
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease, stages 3B-5 Urological and Genital Diseases

Interventions

All patients with CKD Stage 3–5, referred to city nephrology center, are offered dietary counseling by experienced nephrologist. LPD is routinely recommended to all patients at high risk for CKD progr

Sponsors

St-Petersburg City Nephrology center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Confirmed moderate GFR decline rate 2. Patient`s compliance to diet and pharmacological therapy 3. Prolonged history of regular EAA/KAA therapy according to the data from special database, recording patient’s` visits to drugstore for EAA/KAA supplied by budgetary funded source (= 10 consecutive visits with pre-defined for each CKD stage frequency).

Exclusion criteria

Exclusion criteria: 1. Patients with very low life expectancy 2. Patients with rapid CKD progression (more than 10 ml/min/1.73m2 per year)

Design outcomes

Primary

MeasureTime frame
The change in eGFR decline scope (evaluated during two periods of five consequtive outpatient visit during the LPD (<0.6 g/kg/day) supplemented with EAA/KAA compared with that for patients with LPD (0.6-0.8 g/kg/day). The eGFR decline scope is calculated for every patient for both periods as a regression coefficient in 5 pairs: eGFR - visit date (ml/min/ per year). The frequency of the visits is predetermined according CKD stage: quarterly for CKD3, bimonthly for CKD4 and monthly for CKD5.

Secondary

MeasureTime frame
Change in quality of life parameters (evaluated by KDQoL questionnaire)

Countries

Russian Federation

Contacts

Public ContactAlexander Zemchenkov
kletk@inbox.ru+79219180190

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026