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NCT03818568
Supplemented Low Protein Diet and Progression of CKD
NA trial testing ketoanalogues of essential amino acids in Stage 4 Chronic Kidney Disease in 149 participants. Completed in 1 February 2021.
31 January 2020
Quick facts
| Lead sponsor | Coordinación de Investigación en Salud, Mexico |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 149 |
| Start date | 1 November 2017 |
| Primary completion | 31 January 2020 |
| Estimated completion | 1 February 2021 |
| Sites | 2 locations across Mexico |
Drugs / interventions tested
- ketoanalogues of essential amino acids
Conditions studied
- Stage 4 Chronic Kidney Disease — all drugs for Stage 4 Chronic Kidney Disease →
Sponsor
Coordinación de Investigación en Salud, Mexico — full company profile →
Who can join
Adults 60 to 80, any sex, with Stage 4 Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Investigators intend to analyze diets restricted in protein and supplemented with ketoanalogues of essential amino acids, to slow the progress of renal damage and improve nutritional status in diabetic patients over 60 years with stage 4 chronic kidney disease. Evey 2 months, evaluations were performed of renal function (creatinine clearance, serum cysteine, proteinuria) and nutritional status (subjective global evaluation,dominant had pressure strength, body composition by bioelectric impedance, serum transferrin, serum prealbumin and serum aminogram) for a follow-up period of 2 years.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03818568
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03818568 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Coordinación de Investigación en Salud, Mexico
- Last refreshed: 12 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03818568.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing